Medtronic closes enrollment in drug-eluting balloon study | MassDevice.com On Call
January 28, 2013 by MassDevice staff
Medical device titan Medtronic completes enrollment in its IN.PACT SFA II trial evaluating its IN.PACT Admiral drug-eluting balloon in treatment of peripheral artery disease.
MASSDEVICE ON CALL — Minneapolis-based medical device company Medtronic (NYSE:MDT) announced closed enrollment in the U.S. arm of a study evaluating its IN.PACT Admiral drug-eluting balloon.
The multi-center study enrolled 181 patients with peripheral artery disease at more than 40 U.S. clinics, randomizing them to either receive treatment with the IN.PACT Admiral or a traditional, non-coated angioplasty balloon.
Sign up to get our free newsletters delivered straight to your inbox
Medtronic hopes to use the results from the trial in combination with data from IN.PACT SFA I to support a premarket approval bid, according to a press release.
The IN.PACT balloons have been on the market in Europe since 2008, but has yet to win FDA approval for the U.S. Medtronic plans to conduct a total of 24 IN.PACT studies involving about 4,000 patients in more than 80 countries, the company announced last year.
In October 2012 Medtronic closed enrollment in a clinical trial of its IN.PACT Amphirion drug-eluting balloon.
- Show full page
- Login to post comments
-
Permalink
RECENT BLOG POSTS
- Mobilizing on the back end of a disaster
- Rising healthcare costs not directly tied to medical technology, according to study
- CareFusion may be weighing 2 very different deals
- Medical Devices: What does it really mean to be disruptive?
- Smarter strategic moves bode well for Wright Medical
- The IRS, NSA, and Justice Department scandals and what they mean for HIPAA
- A Father's Day remembrance
- What I'd tell the graduating medical school class of 2013
- Silencing immune attacks in type 1 diabetes
- Eucomed guidance clarifies RoHS compliance for medical device companies
Navigation
NEWS
Medical device tax: Consultant calls offshoring concerns 'horse hockey'
Concerns that the medical device tax will push companies to lay off workers and move operations...
FDA clears OrthoSensor's Verasense knee replacement device
The FDA clears OrthoSensor's Verasense device, designed to help surgeons fit knee replacement...
ArtVentive Medical wins CE Mark for peripheral catheter
ArtVentive Medical Group wins CE Mark approval in the European Union for its EOS peripheral vascular...
Recalls: FDA makes Endologix catheter introducer recall Class I
The FDA hits Endologix's catheter introducer device recall with Class I status, its most serious...
pSivida gains big on buyout rumor
A blogger's speculation that pSivida might be in line for a buyout bid sends the ophthalmology...
