FRIDAY, MARCH 11, 201 1 VOL. 15, NO.
43 PAGE 1 OF 10
Large firm mantra; growth
comes by any M&A possible
By OMAR FORD
Medical Device Daily Staff Writer
Large med-tech companies will have to continue to look
toward M&A activities to supplement slower organic growth
in mature markets, according to The Walden Group’s
(Tarrytown, New York), 2010 report. The 30-page document,
which includes acquisitions in the medical device sector,
highlights seven key deals or those transactions with a
value of more than $100 million.
Richard Cohen, president of The Walden Group, a
strategic investment banking firm for the healthcare
industry, spoke to Medical Device Daily earlier this week
about some of the highlights of the report.
“The larger medical device companies have product
lines that are addressing markets that are flattening,” Cohen
said. “They’re under price pressure. So they’re seeing huge
See Walden, Page 6
European Congress of Radiology
Merging MRI with PET Siemens Senate passes patent reform
challenged to prove clinical case as House addresses case law
By JOHN BROSKY
Medical Device Daily European Editor
VIENNA – If you think airport scans are revealing, wait
until you see your PET-MRI image.
For the first time, Siemens has joined PET with magnetic
resonance imaging (MRI) for simultaneous acquisition.
It is a staggering feat of engineering that produces
stunning whole body images illuminating metabolic
processes taking place in vivo and in real time.
The clinical value of PET is well-established in CT with
3.2 million exams ordered up last year worldwide.
But even software-enhanced CT images pale against
the sharp details and soft-tissue contrast of MRI from the
new Biograph mMR shown during the radiology congress
See ECR, Page 8
Don’t miss today’s MDD Extra: Diagnostics
INSIDE: MEDTRONIC OPENS NEW FACILITY IN SINGAPORE TO MEET ASIA DEMAND ..................... 2
VENITI RAISES $13.5 MILLION IN SERIES A FUNDING .......................................... .3
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FDA advisory committee
Former deputy commissioner
alleges bias at gene test panel
By MARK McCARTY
Medical Device Daily Washington Editor
GAITHERSBURG, Maryland – FDA called a meeting of the
molecular and clinical genetics advisory committee to go
over the issue of direct-to-consumer gene testing services,
a topic that was sure to generate controversy given the
goings-on in a hearing on Capitol Hill last year. However,
a former deputy FDA commissioner added to the mix with
allegations that FDA had set up the meeting’s first day in
such a way as to stack the deck against companies that
offer DTC gene testing services.
All the same, the panel sided with FDA in fairly clear
terms on the question of whether a prescription should
be required for tests of a patient’s genetic predisposition
toward a disease state despite accusations of medical
See Advisory, Page 7
Washington roundup
By MARK McCARTY
Medical Device Daily Washington Editor
The U.S. Senate finally passed a patent reform bill
by a blow-out margin of 95-5, a sign that the Senate
takes patent reform seriously, but also a signal that
other considerations no longer trump purely economic
considerations. However, the House Judiciary Committee
held a hearing yesterday to examine the current state
of case law in an effort to flesh out which issues remain
to be addressed via legislation, hinting that a House-
Senate conference will be needed to reconcile what are
almost certain to be two fairly different bills. Meanwhile,
the House is also considering a bill that would change
medical research tax policy, the American Research and
See Washington, Page 9
FRIDAY, MARCH 11, 201 1 MEDICAL DEVICE DAILY™ PAGE 2 OF 10

International report
Medtronic opens new facility in
Singapore to meet Asia demand
A Medical Device Daily Staff Report
Medtronic (Minneapolis) reported the official opening
of its new manufacturing facility, Medtronic Singapore
Operations (MSO). The company said the new facility will
help enhance its manufacturing capabilities to meet the
future expected growth of cardiac devices in Asia.
The Cardiac Rhythm Disease Management business
at Medtronic accounted for $5.2 billion of the company’s
revenue in the 2010 financial year. By the end of 2011,
Medtronic says it will have invested more than $56 million
to the development of its MSO to meet the rising demand
in Asia.
As of November 2011, Singapore will also serve as the
distribution hub for the Asia-Pacific region. The new facility,
which began operations in January, will enable Medtronic
to respond more effectively and efficiently to the needs
of customers and patients with cardiac rhythm disorders,
improving standards of care in Asia, the company noted.
“The completion of Medtronic’s first pacemaker and
leads manufacturing facility in Asia marks an important
milestone in Medtronic’s ever growing presence in
Singapore. Medtronic’s investment is a strong vote of
confidence for our efforts in developing Singapore into
a leading biomedical sciences hub,” Lim Hng Kiang,
Singapore’s Minister for Trade & Industry, said at the
opening ceremony.
In his opening address at the ceremony, Jean-Luc Butel,
executive VP and group president of Medtronic International,
mentioned that Medtronic Singapore Operations will have
hired and trained more than 120 staff by the end of the year
as production increases to meet the growing demand.
“As a leader in the management of cardiovascular and
other non-communicable diseases, we understand well the
MDD’s food for med-tech thought
“I think there will [continue to] be large transactions.
The bar is now raised for companies to make acquisitions.”
– Richard Cohen, president of The Walden Group, on
the increasing likelihood of more blockbuster deals in
the med-tech sector going forward, “Large firm mantra;
growth comes by any M&A possible,” pp. 1, 6.
needs of patients and physicians and are leveraging all of
our global capabilities to address this growing epidemic,”
said Medtronic CEO William Hawkins. “That is why our
manufacturing investment in Singapore is so important. We
now have greatly increased our ability to ensure Medtronic’s
innovative medical technologies will help patients across
emerging Asian markets.”
The Medtronic Singapore Operations is added on
to Medtronic’s stable of more than 250 manufacturing
facilities, sales offices, research centers, education centers
and administration facilities which serve customers and
patients in 120 countries.
STAAR in distribution with Ellex in Australia
STAAR Surgical (Monrovia, California) said it has
entered into an agreement with Ellex Australia (Adelaide)
for the exclusive distribution of STAAR intraocular lenses
in Australia. Ellex will market STAAR’s Visian ICL line of
refractive lenses, STAAR’s intraocular lenses for cataract
patients and related products. STAAR has previously
distributed its products in the region through ConceptVision
Australia, a subsidiary, which is being closed. During 2010
STAAR generated $1.7 million in sales from the region
through a direct team of five employees and generated
about $200,000 in net income.
“We are very pleased to be partnering with Ellex and
to have our products join the Ellex portfolio. We expect
its expertise and reputation to improve our market reach
See International, Page 5

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FRIDAY, MARCH 11, 201 1
Financings roundup
Veniti raises $13.5M
in Series A funding
A Medical Device Daily Staff Report
Veniti (St. Louis) reported it has raised $13.5 million in
Series A financing. Baird Venture Partners, H&Q Healthcare
Investors and H&Q Life Sciences Investors led the round,
and were joined by Prolog Ventures, St. Louis Arch Angels
and a number of individual investors.
The proceeds will be used to acquire two additional
medical device companies and begin commercialization of
multiple products singularly focused on treating chronic
venous disease.
Concurrent with this investment, Veniti will augment
its product portfolio by acquiring two separate medical
device companies, Varix Medical (Sunnyvale, California)
and Teneo Medical Development (Fremont, California).
The Veniti platform will offer medical professionals a
comprehensive solution for treating venous disease,
including a vapor-based endovenous ablation system, a
vena cava filter anchoring technology, and a stent system
designed specifically for treating this complex disease.
Initial products are expected to be available in late 2011.
In other financings activity:
• NovaShunt (Zug, Switzerland), a private Swiss
company that develops fluid management technologies,
reported that it has raised $25 million in a Series B preferred
share financing round co-led by BioMedInvest, Entrepreneurs
Fund and Capricorn Health-tech Fund. Existing investors,
NeoMed and VI Partners, were also significant participants
in the new financing and NeoMed retains its role as the lead
investor and largest shareholder of NovaShunt.
NovaShunt’s ALFApump System is a proprietary,
implantable pump system that continually removes excess
abdominal fluid, known as ascites, in patients suffering
from liver cirrhosis, certain cancers and congestive heart
failure. Refractory ascites occurs when patients with excess
ascites no longer respond to medical therapy and it affects
over 100,000 patients in Europe and the U.S. every year. The
number of patients suffering from ascites is growing due to
the accelerating incidence of hepatitis and obesity-related
liver disease (NAFLD).
The company is currently completing enrollment in the
PIONEER Study, a prospective, multi-center, open label study
designed to evaluate the safety and performance of the
ALFApump System in obviating the need for paracentesis,
the standard therapy for patients with refractory ascites.
Paracentesis is a procedure in which a large bore needle
is inserted into the patient’s abdomen, sometimes weekly
or bi-weekly, to remove between 510 liters of accumulated
ascites. The cumulative cost of repeat paracentesis for
these patients often exceeds $25,000 each year.
• BridgePoint Medical (Minneapolis), a private
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MEDICAL DEVICE DAILY™ PAGE 3 OF 10
company developing technology in the field of interventional
cardiology for crossing coronary and peripheral chronic
total occlusions (CTO), reported that it has completed its
third round of financing, totaling $9.1 million.
The round was lead by a new strategic investor and
joined by existing investors New Enterprise Associates,
Polaris Venture Partners, Foundation Medical Partners and
Michael Berman.
Interventional cardiologists are currently unable to
broadly treat patients with chronic total occlusions which
comprise approximately one third of all patients with
coronary artery disease and approximately one half of
patients with peripheral artery disease. For these patients,
the common alternative is bypass surgery or palliative
care. In order to treat a CTO patient with minimally invasive
therapy, a physician must first successfully cross the
blockage and place a guidewire beyond the occlusion.
BridgePoint Medical’s CrossBoss Catheter and Stingray
System are uniquely designed to facilitate guidewire
placement and subsequent dilatation balloon or Drug
Eluting Stent (DES) placement in this challenging anatomy.
The Series C financing will be used to enable marketing
and sales efforts for BridgePoint’s CrossBoss Catheter and
Stingray System in the U.S., Europe and Japan through the
use of distributors and direct sales. Additionally, BridgePoint
Medical will be initiating a U.S. IDE study of the technologies
in peripheral artery disease in the first half of 2011.
• Medtronic (Minneapolis) reported a registered
offering of $500 million of its 2.625% senior notes due
2016 and $500 million of its 4.125% senior notes due 2021.
Medtronic intends to use the net proceeds for working
capital and general corporate purposes, which may include
repayment of its indebtedness.
The notes will be senior, unsecured obligations of
Medtronic and will rank equally with all of Medtronic’s
existing and future senior, unsecured debt and senior to all
of Medtronic’s subordinated debt.
• Nephros (River Edge, New Jersey) a company that
develops filtration products for therapeutic applications,
infection control, and water purification, reported the
completion of its rights offering and private placement that
together resulted in gross proceeds of nearly $3.2 million
to Nephros.
The aggregate net proceeds received by Nephros from
the rights offering and private placement are estimated
to be about $2.3 million, after deducting the estimated
aggregate expenses of these transactions, the repayment
of the $500,000 note, plus all accrued interest thereon,
issued to Lambda Investors, Nephros’ largest stockholder,
in September 2010 in connection with its loan to Nephros,
the payment of an 8% sourcing/transaction fee ($40,000)
in respect of the note and an aggregate of $100,000 for
reimbursement of Lambda Investors’ legal fees incurred in
connection with the loan and the rights offering.
See Financings, Page 6
FRIDAY, MARCH 11, 201 1
Agreements/contracts
MedAssets gives supply
support to Atlantic Health
A Medical Device Daily Staff Report
Atlantic Health (Summit, New Jersey) has signed
a multi-year contract extension with MedAssets
(Alpharetta, Georgia) for supply chain and clinical resource
management services. The health system realized more
than $13 million in supply chain savings using MedAssets’
technology and services. Atlantic Health has also realized
more than $7.5 million in managed care recoveries over
several years through the use of MedAssets’ revenue
cycle services to accelerate its cash flow and improve
margins.
Atlantic Health uses MedAssets for strategic sourcing or
group purchasing services, supply chain technologies and
analytics solutions. To engage clinicians in the cost reduction
process, Atlantic Health says it relies on MedAssets’ web-
based service line analytics tool and clinical consulting
services to analyze clinical and financial performance across
its service lines and identify variations in clinical resource
use. The health system also uses Strategic Information and
Strategic Information for Pharmacy to increase visibility
into supply chain and pharmacy purchasing and to identify
savings opportunities.
“MedAssets has been an important partner for us in
formulating and executing a supply chain cost reduction
strategy,” said Atlantic Health chief supply chain officer
and director of orthopedic services Joseph DiPaolo. “We
appreciate the flexibility of its purchasing contracts and
how easily MedAssets’ solutions align with our specific
needs. Their ability to drive physician engagement through
expert clinical consulting and state-of-the-art analytics and
technology is really helping us move the needle across our
system when it comes to high-cost supply items.”
Atlantic Health has 1 , 154 licensed beds within its two
hospitals and reported more than 62,000 patient admissions
in 2010 with net patient revenue of $1.1 billion.
MedAssets partners with healthcare providers to
improve financial strength by implementing spend
management and revenue cycle management solutions.
In other agreements/contracts news:
• Caliper Life Sciences (Hopkinton, Massachusetts)
and HistoRx (Branford, Connecticut) reported a
collaboration to co-develop a new generation of tissue-
based imaging and analysis solutions, based on immuno-
fluorescence, that will deliver accurate, quantitative, and
reproducible measurements of proteins in tissue samples.
The collaboration will enable researchers to leverage the
combined imaging and analysis power of Caliper’s Vectra, an
automated multiplexed tissue imaging platform, and Aqua
technology, HistoRx’s proprietary image analysis system, to
provide an integrated platform to advance the identification
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MEDICAL DEVICE DAILY™ PAGE 4 OF 10
and validation of new drug targets and improve assessment
of drug response.
Caliper will have exclusive worldwide distribution
rights for the integrated product in the life sciences
research market as the companies continue to explore
additional collaborative opportunities in clinical research
and diagnostics.
Caliper Life Sciences makes diagnostic tests. HistoRx
makes tissue-based diagnostic solutions.
• Mind Technologies (Cardiff, California) has
signed a distribution and marketing agreement for the
company’s medical applications. Initially, the agreement
will cover the marketing of Mind Mouse and the company’s
new proprietary headset. The Mind Mouse interfaces
a person’s brain with a wireless EEG type headset
to a computer, allowing any medically handicapped
individual to operate all functions, including e-mail and
web browsing, completely hands free without the use of
speech or manual controls.
This agreement is expected to expand to other
applications that the company is developing at this time. In
addition under the agreement, the distributorship will include
storage, marketing, sales, and training on use of the products.
Mind Technologies makes software for thought
controlled technologies, allowing the user to interact with
the computer and other machines through the power of
the mind. The technology involves the use of a wireless
headset, which detects brainwaves on both the conscious
and non-conscious level. This neural processing technology
makes it possible for computers to interact directly with
the human brain. ■
Deals roundup
InfuSystem Holdings in
move to acquire SIC
A Medical Device Daily Staff Report
InfuSystem Holdings (Madison Heights, Michigan), a
provider of infusion pumps and related services, reported
that it has acquired Star Infusion and Compression
(Grosse Ilse, Michigan). Star Infusion is a provider of
ambulatory infusion pumps and related services to
oncologists in Michigan and Ohio.
Sean McDevitt, chairman/CEO of InfuSystem, said, “Star
Infusion has developed a loyal customer following and we
welcome those oncology practices and their patients to
InfuSystem. We are very pleased with the synergies this
acquisition provides and it further solidifies and enhances
InfuSystem’s leading national position in the ambulatory
infusion market.”
The acquisition, which was for cash, is not expected to
materially impact the company’s fiscal 2011 consolidated
financial performance. Further details of the acquisition
were not disclosed. ■
FRIDAY, MARCH 11, 201 1
HIT roundup
San Antonio heart attack patients
benefit from HealthView solution
A Medical Device Daily Staff Report
Lumedx (Oakland, California), a provider of
cardiovascular imaging and information systems (CVIS),
said it has begun implementing the HealthView Chest
Pain Management solution at five Methodist Healthcare
facilities in San Antonio, Texas. Methodist hospitals will
use HealthView to make pre-hospital and emergent
electrocardiographs (ECGs) immediately available to
cardiologists for interpretation, review, and immediate
comparison with previous ECGs, laboratory information
and other crucial patient data. By integrating current and
historical clinical information from disparate systems into a
single view available anywhere with an internet connection,
HealthView Chest Pain Management system bridges
emergency and cardiac medicine, and represents a great
leap forward in the care of chest pain patients, according
to Lumedx.
The HealthView Chest Pain Management solution will
be deployed at San Antonio Methodist hospitals to more
closely connect emergency medical services, emergency
departments and cardiovascular service lines, thereby
accelerating appropriate diagnoses and improving patient
care. Virginia Mason Medical Center (Seattle) is currently
using the same system, the company noted.
“This technology will take us to a new level of cardiac
care,” said Jaime Wesolowski, president/CEO of Methodist
Healthcare. “Methodist Healthcare hospitals see the majority
of cardiac patients in the region and these patients will be
the beneficiaries of this new technology.”
The five Methodist facilities implementing HealthView
are: Methodist Heart Hospital; Methodist Children’s Hospital;
Methodist Metropolitan; Methodist Specialty and Transplant
Hospital; and Methodist Stone Oak Hospital.
In other HIT news:
• Skylight Healthcare Systems (San Diego) reported
that one of its newest clients, the Orthopedic and Spine
Inpatient Surgical Hospital (OASIS; Phoenix) has elected
to maximize their use of the Skylight Access system by
launching the iCarePassport application to improve the
quality of patient care before, during, and after a surgical
procedure.
The unique focus of OASIS will be the treatment of
inpatient musculoskeletal surgical cases. Linking the
patient’s care journey from pre-admission through the
hospital stay and recovery at home, iCarePassport will
extend the benefits of Skylight Healthcare’s Access
Interactive Patient Care System and the wealth of inpatient
services it provides to OASIS patients. Additionally,
iCarePassport includes outcomes modules that patients can
easily complete online which will provide OASIS information
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MEDICAL DEVICE DAILY™ PAGE 5 OF 10
critical to monitoring and measuring evidence-based quality
outcomes.
• WebPT (Phoenix), a web-based electronic medical
records (EMR) system for physical therapists, reported a new
certified billing partner program. WebPT said it is officially
launching the program with two of the industry’s most
widely used physical therapy billing solutions, Kareo and
BMS. WebPT has already made electronic PT documentation
easier, more affordable, and more efficient for today’s
mobile PT, according to the company. The integration of
its fully Web-based EMR system with these popular billing
solutions means smoother, more efficient billing processes
for PT clinics. ■
International
Continued from Page 2
in Australia and New Zealand,” said Don Todd, STAAR’s
president of the Asia Pacific Region. “The Ellex organization
will start highlighting STAAR products at the Asia Pacific
Academy of Ophthalmology (APAO) meeting in Sydney
starting on March 21.”
“We believe with Ellex’s presence in the region, we
should be able to drive additional sales and higher profits
from this territory over time,” said Deborah Andrews, CFO
of STAAR. She added that Ellex will also be purchasing
during the first quarter the current inventory of product in
Australia for about $400,000.” ■
Med-Tech Notes
Guidelines confirm RFA for BE treatment
Barrx Medical (Sunnyvale, California), a maker
of minimally invasive medical devices to remove
precancerous tissue from the gastrointestinal tract,
reported that the American Gastroenterological
Association (AGA) has issued the AGA Medical Position
Statement on the Treatment of Barrett’s Esophagus.
The guideline recommends removal of precancerous
cells in patients with confirmed high-grade Barrett’s
esophagus using endoscopic eradication therapy, such as
radiofrequency ablation (RFA) technology as delivered by
the Barrx HALO Ablation System.
To provide the basis for the medical position statement,
a technical review of the literature was conducted to
explore a series of questions regarding management of
Barrett’s esophagus. The technical review was submitted
to a medical position panel consisting of a diverse group
of stakeholders, including gastroenterologists, a general
surgeon, a pathologist, a health plan representative,
and a consumer/patient advocate. The medical position
statement was then created, which includes information
affirming the utility of RFA therapy as a treatment option
for eradication of Barrett’s esophagus.
FRIDAY, MARCH 11, 201 1
Walden
Continued from Page 1
portions of revenue . . . large businesses with slow growth.
They need to grow, plus they have recovered from the
recession and their balance sheets are very strong so they
have cash and access to significant financings.”
Cohen added that this was going to prompt larger
companies to acquire smaller companies to effectively grow.
One such deal was Boston Scientific’s (Natick,
Massachusetts) $225 million purchase of Sadra (Campbell,
California) (Medical Device Daily, Nov. 22, 2010). Additional
payments of up to $193 million are contingent upon
achievement of specified regulatory and revenue-based
criteria through 2016.
Sadra is developing a fully repositionable device for
percutaneous aortic valve replacement to treat patients with
severe aortic stenosis. The company recently completed
a series of European feasibility studies for its Lotus valve
system, which consists of a stent-mounted tissue valve
prosthesis and catheter delivery system for guidance and
placement of the valve.
The acquisition puts Boston Scientific firmly into the
TAVI market where it goes head to head with Medtronic
(Minneapolis) and Edwards LifeSciences (Irvine,
California).
“Sadra is an acquisition that is Boston Scientific’s entry
into what is arguably the next big growth area.” Cohen
said “It’s an important transformative move by [Boston
Scientific].”
But in no way is it a game changer, Cohen told MDD.
“I’m not sure it’s a game changer, but without [Sadra],
[Boston Scientific] would be a company without a critical
treatment that is getting a lot of attention,” Cohen told MDD.
“Without it they would be stuck in more mundane product
lines that were cutting edge a couple of years ago. It was
required of them. It keeps [Boston Scientific] in the game.”
One of the largest and most important deals of last year
was when Novartis (Basel, Switzerland) acquired Nestle’s
(Veve, Switzerland) 77% stake in Alcon (Huenenberg,
Switzerland) for $51.6 billion (MDD, Dec. 16, 2010).
Novartis said that the merger of the two organizations
was expected to yield a number of benefits to the company
and its customers, including: increased commercial
capability to accelerate sales growth and customer support;
expanded ability to develop eye care products that reach
the market faster; greater patient and market access to
advanced technologies; enhanced product development
and branding opportunities in contact lenses and solutions;
and cost efficiencies that can be reinvested in research and
other growth opportunities.
“The largest deal here in terms of size was the Novartis/
Alcon deal, but that’s by way of size,” he said. “But by way of
qualitative measures . . . its Novartis because it does reflect
certain underlying trends.”
He added that “the underlying dynamic is that there is
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MEDICAL DEVICE DAILY™ PAGE 6 OF 10
a dramatic worldwide aging population – so ophthalmic
surgery and eye conditions are arguably the most prevalent
surgery. It was important to focus on the ophthalmic
area because of its frequency of surgeries and the aging
population. “This very large transaction enables Novartis to
address - I think they quote – 70% or so of eye conditions . . .”
Another important deal cited in the report was the
Ardian (Mountain View, California) acquisition. Medtronic
reported snagging the firm for $800 million plus milestones
for its investigational catheter-based treatment for
uncontrolled hypertension. Ardian’s flagship product,
the Symplicity catheter system, addresses uncontrolled
hypertension through renal denervation, or ablation of the
nerves lining the renal arteries. It has received the CE mark
and Australia’s Therapeutic Goods Administration listing,
but is not yet approved by the FDA.
Speaking on the deal, along with Boston Sci’s acquisition
of Sadra, Cohen told MDD that both were equally important
and brought new dimensions to markets.
“They’re important so much because they’re large
or bringing in current revenue,” he said. “But they reflect
the maturing of mini sectors like orthopedics and
cardiovascular stents and even hypertension drugs. They
open up new minimally invasive treatments that were
formerly conducted by open surgery or drugs.”
The report also included Medtronic’s acquisition of
Invatec (Roncadelle, Italy) for $350 million and its purchase
of Osteotech (Eatontown, New Jersey) for $123 million.
Covidien (Mansfield, Massachusetts) also made the
list with its purchase of ev3 (Plymouth, Minnesota) for $2.6
billion.
Cohen said that he continues to see the big deals
in med-tech’s future, but that doesn’t necessarily mean
there will be deals for the sake of big deals. He said that
companies will look for the best growth markets in a way
that’s complimentary to their offerings.
“I think there will [continue to] be large transactions,”
he said “The bar is now raised for companies to make
acquisitions.” ■
Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com
Financings
Continued from Page 3
Simultaneously with the closing of the rights offering,
Lambda Investors purchased in a private placement
60,194,226 units at the same per unit purchase price of 2
cents, pursuant to a purchase agreement between Nephros
and Lambda Investors.
Nephros issued to Lambda Investors an aggregate of
60,194,226 shares of its common stock and warrants to
purchase an aggregate of 55,651,575 shares of its common
stock. Nephros received nearly $1.2 million in gross proceeds
from its sale of units to Lambda Investors. ■
FRIDAY, MARCH 11, 201 1
Advisory
Continued from Page 1
paternalism by the former FDAer. Left up in the air is the
question of what kinds of evidence the agency will require
to support a claim that a particular single-nucleotide
polymorphism (SNP) – or a group of SNPs – is indicative of
propensity toward a disease state.
The issue blew into public view last year after FDA
commenced with enforcement, followed by a hearing in the
House Energy and Commerce oversight and investigations
subcommittee during which lawmakers on both sides of
the aisle blasted sponsors of DTC gene tests. The latest
FDA employee to take umbrage with the agency was
Mary Pendergast, who said she had spent 18 years at FDA,
the first 11 as a lawyer and the last seven as deputy FDA
commissioner. “I think this panel has not been well served
by this hearing,” said Pendergast, who started by asserting
that the FDA presentations should have been held the first
day of the hearing rather than the second. Pendergast also
noted “there were no enthusiasts [for DTC testing] invited to
speak” on the first day. She added that while DTC opponents
received 30 minutes to make their cases on the first day of
the hearing, only 10 minutes were set aside for presentations
by supporters on the second day.
Regarding the notion of unfettered access to personal
genomic information, Pendergast said, “the bottom line
from actual studies is that when people attempt to learn
something, they are not upset at what they learn.” She
also took aim at the report filed by the Government
Accountability Office (GAO) for last year’s hearing in the
House, citing “a couple of problems” with the GAO report.
She said that despite GAO’s claims, “the concordance on the
actual analytical validity was 100%.” She also pointed out
“when the GAO sent in the [samples of] spit to the companies,
they sent it in twice” to the firms with two different sets of
demographic data.
Taking on medical paternalism, Pendergast said “the
medical profession has objected every time the government
has attempted to give direct genetic information” to
consumers and patients. She pointed out “there haven’t been
major problems with HIV and pregnancy tests. But frankly,
its medical paternalism” that drives physician resistance to
DTC gene tests.
Pendergast also hinted at a profit motive behind
physician attitudes, saying that for doctors, DTC tests
present “a problem with economics.”
“If we stick to your recommendation that people go
to you twice,” first for the prescription and then for a
consultation, “you get money twice.” She also remarked,
“your labs will be paid for the testing” if DTC companies
can’t do business.”There’s nothing wrong with saying [a
test] tells only part of the story,” she continued, but argued
that the idea that a positive outcome in a DTC test should
compel a referral to a profession “is beyond the scope of
government’s control over consumers.”
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MEDICAL DEVICE DAILY™ PAGE 7 OF 10
Alberto Gutierrez, PhD, director of the Office of In
Vitro Diagnostics at FDA, said in response to Pendergast’s
allegations about a stacked deck, “FDA tried very hard
to find a set of speakers that was balanced” and that he
“would be surprised to hear that the speakers are anti-
DTC testing.” Upon further inquiry by Medical Device Daily,
FDA spokeswoman Erica Jefferson said in an e-mail, “FDA
did not ask speakers about their position up front, but
rather invited individuals we believed had the ability to
share unique and relevant insights on the various aspects
of the topic being considered by the panel.” She said FDA
“took away a number of useful insights that we’ll continue
to review in the weeks ahead to determine the best path
forward for regulating these complex testing devices.”
Also addressing the panel during the open public
hearing was Diana Zuckerman, PhD, of the National
Research Center for Women and Families (Washington),
who took a swipe at Pendergast with the remark, “I’m not a
lawyer.”
Zuckerman said FDA is not a particularly good source
of patient information generally speaking. “I’ve seen patient
booklets approved by FDA,” some of which “are 50 pages
long . . . and not consumer friendly in any way, shape or
form,” adding that staff at the National Institutes of Health
“are much better at providing patient information.”
“I believe that the standard for these tests should be
higher than for tests interpreted by physicians,” Zuckerman
said, because “the risks are higher and the benefits are
questionable.”
As has been widely reported, the panel largely
concluded on the first of the two-day hearing that for
the most part, such tests should be available only with a
prescription. During the panel’s responses to the FDA
questions, the panel indicated that risk information in
gene testing reports should probably refer principally to
absolute risk of acquiring a disease rather than relative
risk, but the panel was not fond of the idea that a given
test should be available to only some demographic groups.
Panelist David Ranshoff, MD, of the University of North
Carolina (Chapel Hill, North Carolina) said “relative risk has
been almost outlawed by the medical journals” because of
contextual issues, while another panelist said “absolute risk
is what patients tend to understand the best,” suggesting
that absolute risk “be very prominently displayed” in gene
testing reports.
As for what kinds of data should be required to
establish the validity of a single-nucleotide polymorphism’s
(or a group of SNPs) predictive power, several panelists said
cohort studies might offer data that case control studies
will not, although panelist Ralph D’Agostino, Sr., PhD, of
Boston University (Boston) said “even cohort studies
would be difficult.”
Jim Prutow, a partner in the management consulting
firm PRTM (Washington) told Medical Device Daily that
See Advisory, Page 10
FRIDAY, MARCH 11, 201 1
ECR
Continued from Page 1
that ended here earlier this week.
The challenge ahead for Siemens is now demonstrating
the clinical value for this high-tech accomplishment.
Absence of radiation is a big plus
CT exams today account for a third of all medical
radiation, though they only represent about 8% of exams
made by all modalities.
Yet, CT is so much faster than MRI, and so well-established
in clinical literature that it will be difficult to dislodge it as
the preferred, incumbent method for diagnostics.
The first Biograph mMR was installed at the prestigious
Klinikum rechts der Isar at the Technical University in
(Munich, Germany).
Alexander Drzezga, MD, from the university’s
department of nuclear medicine was been responsible for
the system delivered in November 2010.
He believes combining PET with MRI offers numerous
clinical advantages, and his studies include a head-to-head
comparison with PET/CT.
“Many neurological conditions are suitable for
evaluation with PET/MR, including neurodegenerative
disorders, dementia, epilepsy, and brain tumors,” he said.
PET-MRI also shows promise for the evaluation of
the cardiac system, as well as inflammation and vascular
conditions, he said.
Jens-Christoph Georgi, Siemens Global Product
Manager for the Biograph mMR told Medical Device Daily the
company signed a research agreement with Klinikum rechts
der Isar to identify the most promising and relevant clinical
applications.
A Biograph mMR was installed in early March 2011 at the
University of Tübingen which also agreed to a Siemens
research agreement.
Similar contracts are being set with clinics in Essen and
Leipzig where the Biograph mMR will be installed this year.
While FDA approval is pending for the Biograph mMR,
Massachusetts General Hospital (Boston) has ordered
the scanner and Georgi told MDD two further installations
are expected in the U.S.
Markus Schwaiger, MD, director of the clinic for nuclear
medicine at the Technical University of Munich Hospital
said the promise of MRI is “to diagnose diseases at a very
early stage, to see the progression of disease and to use that
information to develop a therapy plan precisely focused on
the respective patient.”
“We plan to use the system for cancer follow-up and for
reducing radiation exposure to patients,” he said.
PET-MRI also creates opportunities the development of
new biomarkers or new therapeutic approaches.
Reinventing PET detectors
The current generation of PET detectors are tubes that
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MEDICAL DEVICE DAILY™ PAGE 8 OF 10
pick up the signal of the radioisotopes coursing through the
bloodstream.
The magnetic force of the MRI steady field magnet is
already powerful enough to makes syringes and scalpels fly
through the air.
There is no question of bringing the delicate vacuum
photomultiplier tubes used in PET anywhere near that
magnet, nor the more disruptive electromagnetic field
created by the gradient pulses of the radiofrequency (RF)
coils used in MRI scanning.
Last year at ECR, Philips Healthcare (Eindhoven, the
Netherlands) introduced a silicon-based photomultiplier
technology for a separately shielded PET detector unit that
is safe enough to place next to the MRI. (MDD, Mar 10, 2010)
GE Healthcare (Chalfont, UK) is pursuing this approach
as well.
By placing the patient on a table that turns between the two
machines, the PET scan and the MRI exam can be conducted
sequentially, and close enough in time to allow a reliable
anatomical registration for an overlay of the two images.
Siemens engineers went further, for the first time
placing a ring of avalanche photodiode (APD) PET detectors
inside the bore ring of a 3 tesla Verio MRI for simultaneous
acquisition of images from both modalities.
While the APD detectors are insensitive to the steady
field of the magnet, they are shielded from the gradient field.
Siemens solved technical issues for scaling up the APD
detection surface to 26 cm, enabling faster exam times with
the largest PET coverage area available, according to Georgi.
Engineers also succeeded in stacking offset layers of
crystal detectors capable of collecting more photons from
the PET isotope.
Placed inside the 70 cm ring of the Verio MRI, the shielded
detector ring reduces the bore size for examination to 60
cm, a standard size for whole body imaging, but challenged
by some patient populations.
Shown the new Biograph mMR, Allen Li, MD, from the
Medical College of Wisconsin (Milwaukee), offered the
positive note that “about 90% of our patients would fit into
the Biograph.”
Critical for MRI acquisition are the RF coils, and a
competitive advantage Siemens engineered into the
Biograph mMR are an array of parallel imaging coils enabling
a whole body scan without repositioning the patient.
For an examination, a patient is positioned in the head
coil and aligned on top of the embedded spine coil while
four mMR RF coil pads are placed the length of the patient’s
body.
The Biograph system can handle up to 76 individual
coil elements receiving from those elements up to 32 RF
channels, allowing coverage of 205 cm or six feet, nine
inches.
Scan times are estimated at 30 minutes for whole body,
he said, though the Klinikum group in Munich reports an
average of 20 minutes. ■
FRIDAY, MARCH 11, 201 1
Washington
Continued from Page 1
Competitiveness Act of 2011, even as the device tax repeal
bill continues to gather sponsors.
The difficulty for fans of patent reform, whatever their
views of the various issues connected with the idea, is that
passage of a bill in one chamber of Congress guarantees
nothing about what will happen in the other. The House
passed a patent bill in 2007, only to watch the Senate focus
its efforts on other priorities. Since then, no bill had passed
until earlier this week, although the Obama administration
has thrown its weight behind the Senate bill and, implicitly,
reform in general.
In a statement e-mailed to Medical Device Daily,
Mark Leahey, president/CEO of the Medical Device
Manufacturers Association (MDMA; Washington)
said the association “appreciates the Senate’s efforts to
improve the patent bill from earlier versions,” a comment
probably intended to address provisions for damage
awards. Leahey went on: “While there are positive
developments in this legislation, such as the end of fee
diversion for the United States Patent and Trademark
Office, MDMA remains concerned that establishing a
new post-grant review process will overburden PTO and
provide a potential vehicle for abuse by some parties.”
Leahey concluded that a modern patent system is
“absolutely critical for medical device innovators to have
an adequate assurance that their intellectual property
will be protected and we look forward to working with
both parties and chambers of Congress to achieve this
goal.”
Bill would make R&D tax credit permanent
Another item of interest arising from inside the Beltway
is a bill that would permanently fix the research and
development tax credit into U.S. tax law, a move heralded
by one of the other major device industry associations, the
Advanced Medical Technology Association (AdvaMed;
Washington).
Authored in part by Rep. Erik Paulsen (R-Minnesota),
author of the best-supported device tax repeal bill
currently in play in Washington, H.R. 942 states
specifically that it is drafted “to amend the Internal
Revenue Code of 1986 to extend the research credit
through 2012 and to increase and make permanent the
alternative simplified research credit.” The principal
sponsor of the bill is Rep. Kevin Brady (R-Texas), who
is a member of the House Energy and Commerce
Committee.
In a March 9 statement, Steve Ubl, president/CEO of
AdvaMed, said American device makers commend the
authors of the bill, adding that while the U.S. “is currently
the recognized world leader in medical technology, its
continued leadership is by no means assured.” He said
U.S. tax policy must “sufficiently support research and
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MEDICAL DEVICE DAILY™ PAGE 9 OF 10
development for industries like medical technology to level
the playing field with foreign governments eager to attract
American jobs and develop home-grown competitors to
American firms,” a failure of which would “put in jeopardy
the future of our nation’s economy.”
“We believe the bill introduced today would
contribute to continued U.S. leadership in medical
technology, as well as our industry’s ability to provide
patients here in the U.S. and around the globe with
innovative life-saving and life-enhancing technologies,”
Ubl said.
Medtronic resolves FDA warning letters
Medtronic (Minneapolis) said the FDA has informed the
company that issues noted in two warning letters – one from
November 2009 regarding the company’s Mounds View,
Minnesota facility and another from June 2009 regarding
the company’s manufacturing facility in Juncos, Puerto Rico
– have been resolved.
“We are encouraged that the action plans implemented
by our teams have resolved the observations identified
by the FDA in both warning letters,” said William Hawkins,
chairman/CEO of Medtronic. “We will continue to provide
the highest quality products and we are actively working
to ensure the changes we have made are appropriately
incorporated across all of our global facilities. We have
developed a culture of prevention and accountability
across our entire enterprise and we will continue to invest
aggressively in the continuous improvement of our people,
processes and products.”
Paulsen’s device tax bill gains five sponsors
Rep. Erik Paulsen continues to draw sponsors for his
bill aimed at repealing the device tax imposed as part of the
Patient Protection and Affordable Care Act of 2010. The bill
had attracted 103 sponsors at the beginning of the week, but
has pulled in another five sponsors according to the website
www.govtrack.us.
The bill has not garnered any additional support,
however, from the Democratic Party, which still has only
three members who have signed on to support the bill. While
the House GOP needs no help from Democrats to pass the
bill, getting a companion bill through the Senate will require
substantial help from Senate Democrats, who number in the
majority. The Senate Finance Committee, which would have
at least some jurisdiction over such legislation, is chaired
by the author of one of the healthcare reform bills last year
and the bill that originally included the device tax, Max
Baucus (D-Montana). Given the budget-balancing sentiment
prevailing in Washington this year, Baucus could demand
offsets, which would be hard to come by in the current fiscal
environment. ■
Mark McCarty, 703-268-5690
mark.mccarty@ahcmedia.com
FRIDAY, MARCH 11, 201 1
People in the News
• Agendia (Irvine, California) has named David
Macdonald as the company’s chief operating officer, Mark
Willig as executive VP of North American sales, and Doug
Bradley as VP of global marketing. Macdonald has been with
Agendia for the past eight months in a consulting role. Willig
previously was GM and chief commercial officer at Exiqon.
Bradley was marketing manager at SenoRx. Agendia makes
genomic tests for tumor gene expression profiling.
• Howard Bauchner, MD, will become the next JAMA
Editor-in-Chief on July 1, according to the American Medical
Association (Chicago). Bauchner is currently the editor-in-
chief of the Archives of Disease in Childhood, the official
publication of the Royal College of Paediatrics and Child
Health in the UK. Bauchner is a professor of pediatrics and
community health sciences at Boston University Schools of
Medicine and Public Health.
• Nordion (Ottawa) has named Janet Woodruff of BC
Hydro and Sean Murphy, formerly of Abbott Laboratories to
its board. Woodruff is the VP and special advisor of BC Hydro.
Murphy was VP of licensing and business development for
Abbott Laboratories for 10 years, prior to his retirement in
2010. Nordion is a specialty health science company that
provides products used for the prevention, diagnosis and
treatment of disease.
• PinPointe (Chico, California) said that Adam
Landsman will head up the company’s medical advisory
panel. Adam Landsman, DPM, is an assistant professor of
surgery, at Harvard Medical School and is also the director
of research for the California School of Podiatric Medicine
at Samuel Merritt University. PinPointe makes laser-based
devices for the treatment of infections.
Product Briefs
• Covidien (St. Louis) said the FDA has approved
the use of molybdenum-99 (Mo-99) derived from low-
enriched uranium (LEU) in the production of technetium-
99m (Tc-99m) generators. Tc-99m is a medical isotope,
used in more than 80% of all nuclear medicine studies,
supplied to hospitals and nuclear pharmacies by
Covidien’s Mallinckrodt business. Tc-99m is produced
when Mo-99 decays following uranium irradiation. Tc-
99m is a critical medical isotope used in diagnostic and
functional studies of organs and anatomical systems.
The information from these studies is used by many
medical specialists (including radiologists, cardiologists,
nephrologists and oncologists) to better diagnose and
treat patients.
• Teleflex (Limerick, Pennsylvania) said its Arrow
NextStep Antegrade Chronic Hemodialysis Catheter has
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MEDICAL DEVICE DAILY™ PAGE 10 OF 10
Advisory
Continued from Page 7
in the current environment, the impact on companies in
this space will be substantial. “I hope FDA, when they take
the recommendations, doesn’t require prescriptions for
everything, but use a risk-based methodology” to make the
call. Still, firms “are going to be significantly impacted” by
further regulatory requirements, he said.
“What I believe is going to happen is a number [of
firms currently in the business] will be acquired by more
established IVD firms,” partly because these smaller firms
don’t have the quality control/regulatory affairs staff and
“have a difficult time creating the processes and the culture
that’s required,” Prutow said. He said that the larger firms
will have the genomic capability to fully exploit any form
of DTC marketing to the fullest and have an interest in
molecular diagnostics, “so we’re going to see more and
more companies look at how they’re going to grow in the
molecular [diagnostic] space,” which he said is the fastest
growing space in the IVD field.
Prutow pointed out that investors are very likely to
rethink their commitments to at least some of the smaller
firms in the field. “I think it’s going to be challenging to
continue to get funding” for firms that are VC-backed, he
said. ■
Mark McCarty, 703-268-5690
mark.mccarty@ahcmedia.com
received market clearance from the FDA. The catheter
is designed to attain long-term vascular access for
hemodialysis and apheresis. It is indicated for use in adult
patients. The catheter includes a step-tip catheter’s ease
of insertion and a split-tip catheter’s sustained high flow.
Compared to traditional chronic hemodialysis catheters, the
ports are reversed to match the heart’s natural blood flow
dynamics. The venous port releases blood into the superior
vena cava. The arterial port draws blood from the right
atrium. Side holes on the tip of the catheter are designed
to pull blood from all sides of the catheter. The ports are
significantly separated to enhance flow and minimize
recirculation, the company said.
• XDx (Brisbane, California) said Aetna, a provider
of healthcare insurance, has determined that AlloMap is
“medically necessary” for monitoring rejection in heart
transplant recipients more than one year after a heart
transplant. AlloMap Molecular Expression Testing is a non-
invasive gene expression test used to aid in the identification
of heart transplant recipients with stable allograft function
who have a low probability of moderate/severe acute
cellular rejection at the time of testing in conjunction with
a standard clinical assessment. AlloMap testing measures
the expression levels of 20 genes from a blood sample. The
combined expression of these genes is represented as an
AlloMap test score.
MDD’s Diagnostic Extra
ADDITIONAL DEVELOPMENTS IN ONE OF MED-TECH’S KEY SECTORS
FRIDAY, MARCH 11, 201 1 PAGE 1 OF 2

Keeping you up to date on recent developments in diagnostics . . .

New test is more accurate in detecting STI disease . . . A study from the microbiol-
ogy lab at Rhode Island Hospital (Providence, Rhode Island) has found that a new test may be more accurate in
identifying a common sexually transmitted infection (STI), Trichamonos vaginalis (TV). The researchers also noted
a high prevalence of TV in women in the 36- to 45- year-old age group – a group not normally included in the recom-
mended STI screening criteria. The study is now published online in advance of print in the Journal of Clinical Micro-
biology. TV is a STI that can affect both men and women, and its symptoms can be associated with many different
conditions. Its true prevalence and clinical impact is unknown because current methods of detection exhibit poor
sensitivity when compared to molecular amplification methods. The lead author of the study, Kimberle Chapin, MD,
director of the microbiology lab at Rhode Island Hospital, says, “Despite a worldwide prevalence rate likely to be
double that of gonorrhea or chlamydia combined, TV is not currently a reportable disease in the United States.” The
authors tested the effectiveness of the only FDA cleared diagnostic test for differentiating and identifying the patho-
gens associated with bacterial vaginitis compared with another test that uses a special type of amplification for the
detection of TV, known as the APTIMA assay. Clinical trials of the assay were recently completed and it has been
submitted to the FDA for clearance. The authors studied the specimens from 766 women. Through their study, they
found that the AFFIRM assay, which is commonly used in OB/GYN patients, produced both false positive and false
negative results, while the APTIMA assay detected 36% more TV-infected women yielding a sensitivity of 100% and
no false positives. Chapin says, “We also found that TV was most prevalent in women ages 36 to 45 and in women
ages 51 to 60. While this was definitely surprising and a new finding in these age groups, this data has now also been
substantiated in the FDA clinical trial data involving multiple sites in the U.S. including Rhode Island Hospital. In the
Rhode Island population with a low prevalence of sexually transmitted infections, we found that Trichomonas
vaginalis infection was higher than that of chlamydia and gonorrhea, supporting the need for routine testing for TV
and suggesting a different reason for why women may be seeing their physicians with certain gynecologic com-
plaints.”

Velcro-like nanoscale technology identifies, grabs CTC’s . . . Circulating tumor

cells, which play a crucial role in cancer metastasis, have been known to science for more than 100 years, and
researchers have long endeavored to track and capture them. Now, a University of California, Los Angeles
(UCLA) research team has developed an innovative device based on Velcro-like nanoscale technology to efficiently
identify and “grab” these circulating tumor cells, or CTCs, in the blood. Metastasis is the most common cause of
cancer-related death in patients with solid tumors and occurs when these marauding tumor cells leave the primary
tumor site and travel through the blood stream to set up colonies in other parts of the body. The current gold stan-
dard for determining the disease status of tumors involves the invasive biopsy of tumor samples, but in the early
stages of metastasis, it is often difficult to identify a biopsy site. By capturing CTCs in blood samples, doctors can
essentially perform a “liquid” biopsy, allowing for early detection and diagnosis, as well as improved monitoring of
cancer progression and treatment responses. In a study published this month and featured on the cover of the jour-
nal Angewandte Chemie, the UCLA researchers report the successful demonstration of this “nano-Velcro” technol-
ogy, which they engineered into a 2.5-by-5–centimeter microfluidic chip. This second-generation CTC-capture
technology was shown to be capable of highly efficient enrichment of rare CTCs captured in blood samples col-
lected from prostate cancer patients. The new approach could be even faster and cheaper than existing methods,
and it captures a greater number of CTCs, the researchers said. The prostate cancer patients were recruited with the
help of a clinical team led by physicians Matthew Rettig, of the UCLA Department of Urology, and Jiaoti Huang, of the
UCLA Department of Pathology and Laboratory Medicine. The new CTC enrichment technology is based on the
research team’s earlier development of ‘fly-paper’ technology, outlined in a 2009 paper in Angewandte Chemie. The
technology involves a nanopillar-covered silicon chip whose “stickiness” resulted from the interaction between the
nanopillars and nanostructures on CTCs known as microvilli, creating an effect much like the top and bottom of

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FRIDAY, MARCH 11, 201 1 MDD’S DIAGNOSTIC EXTRA PAGE 2 OF 2

Velcro. The new, second-generation device adds an overlaid microfluidic channel to create a fluid flow path that
increases mixing. In addition to the Velcro-like effect from the nanopillars, the mixing produced by the microfluidic
channel’s architecture causes the CTCs to have greater contact with the nanopillar-covered floor, further enhancing
the device’s efficiency.

Thermosensor can detect early signs of atherosclerosis . . . A new study published

in the Annals of Biomedical Engineering shows that a Micro-Electro-Mechanical System (MEMS) thermal sensor
deployed by an angiogram catheter can detect the earliest stages of atherosclerosis. The MEMS thermal sensor used
convective heat transfer to detect pre-atherosclerotic regions of arteries that otherwise showed no clinical signs of
atherosclerosis. Although diet and lifestyle changes can often reverse atherosclerosis in its earliest stages, no real-time
means of detecting pre-atherosclerotic regions exists. The MEMS sensor method has the advantage of being both
minimally invasive and sensitive. The technology has the potential for widespread and rapid application during diag-
nostic angiograms. The study’s lead author, Tzung Hsiai, an Associate Professor of Biomedical Engineering and Cardi-
ology at the University of Southern California (Los Angeles) said, “The innovation of this study lies in the convec-
tive heat transfer strategy to detect changes in output voltage signals in the non-obstructive, albeit inflammatory and
otherwise considered normal arterial regions.” Scientists have demonstrated that frictional force acting on the walls of
vessels by blood flow, known as shear stress, is intimately involved in oxidative stress and inflammatory responses
that lead to atherosclerosis. In athero-prone regions, the flow is disturbed, yet detection of changing flow patterns in
real-time remains a challenge. Hsiai’s group developed a micro-electro-mechanical system (MEMS) by depositing tita-
nium and platinum on a flexible polymer membrane and patterning them to form the sensing elements. They deployed
the sensor via an angiogram catheter into the aortic and abdominal arteries of rabbits that had eaten a high fat, high
cholesterol diet, and a control group that had eaten a normal diet. An electric current passed through the sensing ele-
ment and generated a thermal layer in the flow field, from which convective heat transfer was measured as a function
of the voltage signals. In the regions of atherosclerotic lesions, blood flow is disturbed. This causes changes in convec-
tive heat transfer from the sensing element to the flow field, and thus, changes in voltage signals. The sensor measured
a high voltage upstream from the part of the blood vessel that harbored the atherosclerotic plaque, and a low voltage
downstream. The scientists concluded that the MEMS thermal sensor method could sensitively detect pre-atheroscle-
rotic regions that otherwise showed no clinical signs of atherosclerosis.

Simple blood test can detect likelihood of Down Syndrome . . . Researchers say
that a simple blood test can predict whether a baby is likely to have Down Syndrome. DNA differences between the
mother and the fetus can be shown to accurately predict which fetuses are at risk of developing the syndrome,
Reuters reports. “We believe we can modify this test and make it much easier and simple... (and then) we can have
something ready to be introduced into the clinic,” Philippos Patsalis, medical director of the Cyprus Institute of
Neurology and Genetics explained. Down Syndrome occurs in 1 in 700 live births and is the most common genetic
cause of mental retardation. The risk of having a baby with Down Syndrome occurs when a child has three copies
of chromosome 21 instead of the normal two. The risk increases as women get older. The risk for a 40-year-old
mother is 16 times that for one who is 25. Amniocentesis is the current test that is performed to find if a baby is likely
to be born with Down Syndrome. This test is generally done at about 15 or 16 weeks gestation and involves taking
amniotic fluid from the mother by inserting a hollow needle into the uterus. This test also carries a small risk of
spontaneous miscarriage, generally 1 to 2%, and scientists have been looking for new less invasive ways to test for
Down Syndrome and other genetic issues. Patsalis calls the results “very exciting” but said the test needs to be tri-
aled in a larger study of about 1,000 pregnancies and could lead to changes in clinical practice within the next few
years. Patsalis’ method examines differences in the DNA methylation patterns, which control levels of genes
between mother and fetus. The test involves taking a small amount of blood from the mother when she is between
the 11th and 13th week of her pregnancy to detect extra copies of chromosome 21 in the fetus. In the initial, small trial
of 40 pregnant women, researchers were able to correctly diagnose 14 cases of extra copies of the chromosome, and
26 normal fetuses, highlighting its clinical potential. “Such a non-invasive approach will avoid the risk of miscar-
riages of normal pregnancies caused by current, more invasive procedures,” researchers conclude in their findings,
published in a recent issue of Nature Medicine.

– Compiled by Omar Ford, MDD Staff Writer

omar.ford@ahcmedia.com

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