6/19/2019 FDA gives Medtronic's PillCam OK for expanded indication on major risk patients | FierceBiotech

 

MedTech

FDA gives Medtronic's PillCam OK for expanded indication on major risk patients

by Joseph Keenan | Mar 31, 2016 10:37am

The FDA has cleared Medtronic's ($MDT) PillCam COLON 2 ingestible capsule for an expanded indication in
patients who are at major risks for colonoscopy or moderate sedation.

The regulatory agency's expanded indication of the device is for the detection of colon polyps in patients with a
history of gastrointestinal bleeding of lower gastrointestinal origin, the company said in a release. The new
indication is targeted only at patients with major risks for colonoscopy or moderate sedation, but who can handle
a colonoscopy and moderate sedation in the event a major abnormality is found by the capsule endoscopy.

The device is about the size of a vitamin and is swallowed by the patient without the need of sedation, Medtronic's PillCam--Courtesy of Given

anesthesia or radiation. Imaging

"The new indication allows gastroenterologists to provide their at-risk patients with a non-invasive and radiation-free alternative to traditional
colonoscopy," Dr. Douglas Rex, director of endoscopy at the Indiana University School of Medicine, said in a statement.

Colon cancer is the second leading cause of cancer death in the U.S. among men and women combined with an estimated 136,000 people in the country
diagnosed with colorectal cancer each year. When diagnosed at a localized stage, the overall 5-year survival rate is 90%, according to studies cited by
Medtronic.

The PillCam COLON 2 device was previously cleared by the FDA for visualization of the colon and the detection of colon polyps in patients following an
incomplete colonoscopy with adequate preparation, and a complete evaluation of the colon was not technically possible. Of the 14 million colonoscopies
performed in the U.S. every year, more than 3 million of those procedures are done for lower gastrointestinal bleeding with about 600,000 of the
procedures done on patients who are at an elevated risk for complications.

Though Medtronic has dominated the arena of ingestible endoscopic imaging capsules the competition has begun to heat up. Earlier this week,
California-based Rock West Medical Devices raised $1.25 million in equity to advance its MoPill, an ingestible capsule that measures the motility--
spontaneous and active movement--of the gastrointestinal tract.
Scroll Down To
Additionally, MIT researchers are developing a capsule that measures heart and respiratory rates in real time. And a University of Glasgow team is
working on a capsule that images with nonvisible light and could be used to diagnose gastrointestinal cancers.

- here's the Medtronic release

Suggested Articles

MedTech

FDA clears J&J and Grifols' blood-stopping protein spray

by Conor Hale
Jun 19, 2019 12:44pm

https://www.fiercebiotech.com/medical-devices/fda-gives-medtronic-s-pillcam-ok-for-expanded-indication-major-risk-patients 1/4
6/19/2019 FDA gives Medtronic's PillCam OK for expanded indication on major risk patients | FierceBiotech

 MedTech 
Bio-Techne nets FDA breakthrough ticket for prostate
cancer test
by Conor Hale
Jun 19, 2019 10:33am

MedTech

Qiagen launches one-stop antimicrobial resistance

database
by Conor Hale
Jun 18, 2019 11:17am

Scroll Down To

GET THE NEWSLETTER

Subscribe to FierceBiotech to get biotech industry news and updates delivered to your inbox.

Email

https://www.fiercebiotech.com/medical-devices/fda-gives-medtronic-s-pillcam-ok-for-expanded-indication-major-risk-patients 2/4
6/19/2019 FDA gives Medtronic's PillCam OK for expanded indication on major risk patients | FierceBiotech
I acknowledge that I may receive emails from FierceBiotech and on behalf of their trusted partners.

 
SIGN UP

About the Author

Joseph Keenan
Contributing Writer


Scroll Down To

https://www.fiercebiotech.com/medical-devices/fda-gives-medtronic-s-pillcam-ok-for-expanded-indication-major-risk-patients 3/4
6/19/2019 FDA gives Medtronic's PillCam OK for expanded indication on major risk patients | FierceBiotech
GENERAL CONTACT NEWSLETTERS CONNECT

Home Advertise Subscribe

Privacy About Us Manage Subscriptions

Terms Of Use

RSS

© 2019 Questex LLC. All rights reserved. 3 Speen Street, Suite 300, Framingham, MA 01701

Reproduction in whole or part is prohibited.

Scroll Down To

https://www.fiercebiotech.com/medical-devices/fda-gives-medtronic-s-pillcam-ok-for-expanded-indication-major-risk-patients 4/4