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.
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 have 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.
New Jersey health system pays $12.6M to resolve illegal kickbacks case
New Jersey’s Cooper Health System must pay $12.6 million to resolve a whistleblower lawsuit charging the hospital with paying millions in illegal kickbacks for physician referrals.
"Executives in Residence" program pairs life science entrepreneurs with seasoned players
Texas-based UNT Health Science Center’s unique Executives in Residence program aims to bolster life science entrepreneurs with the support of industry experts.