Medtronic creeps toward FDA nod for drug-eluting balloon
|Medtronic is working to make the IN.PACT Admiral the first drug-eluting balloon approved by the FDA--courtesy of Medtronic|
Medtronic is testing how well the tech treats peripheral artery disease in the superficial femoral and proximal popliteal arteries, enrolling 181 patients across about 40 sites around the U.S. and another 150 in Europe. All that data will go to support a PMA application, Medtronic says, once the company has reached its primary 12-month patency endpoints.
The latest studies follow on positive results from Medtronic's previous trials overseas, Senior Vice President Tony Semedo said in a statement, and the balloons have demonstrated themselves superior to on-the-market devices in lesion revascularization levels, late lumen loss reduction and adverse event reduction.
"With 7 femoropopliteal trials featuring IN.PACT drug-eluting balloons presented at medical meetings and 5 of them already published in peer-reviewed journals, Medtronic is on track to deliver this technology to U.S. physicians in a timely manner with an unprecedented volume of high-quality clinical data to support its adoption," Semedo said.
Medtronic's not the only devicemaker working to get a drug-eluting balloon on stateside shelves. Biotronik has posted some positive trial results for its Passeo-18 Lux, and Covidien ($COV) recently bought a California startup for an undisclosed amount to get its hands on the company's balloon, which it's targeting for a 2017 PMA.
- read Medtronic's release