|Medtronic has submitted the first module of its FDA application for the IN.PACT Admiral.--Courtesy of Medtronic|
Medtronic ($MDT) wants to be first on the U.S. market with a drug-eluting balloon, submitting the first portion of its FDA application and eyeing a 2015 launch for its peripheral artery disease-treating device.
The IN.PACT Admiral is designed to treat atherosclerotic lesions in the superficial femoral artery, and the company is taking the new modular approval track as it works with the FDA, turning in a first phase of clinical data from its ongoing pivotal trials.
The total Admiral clinical program includes 24 studies on more than 4,200 patients around the globe, and Medtronic believes it will have the safety and efficacy data to win the FDA's blessing and get the device on U.S. shelves by the second half of 2015, Endovascular Therapies President Tony Semedo said.
"In the meantime, we will continue working with leading healthcare providers and researchers around the world to amass clinical and economic evidence to support the global adoption of this innovative medical technology as an important addition to the treatment options for peripheral artery disease in the lower extremities," Semedo said in a statement.
And while the world's largest devicemaker may lead the race to get a drug-eluting balloon to market in the U.S., its rivals aren't far behind.
This year, Covidien ($COV) spent an undisclosed sum on California's CV Ingenuity to pick up a PAD balloon of its own, and, in 12-month data presented at EuroPCR in the spring, the devicemaker reported 87% primary patency in treated arteries with no deaths or amputations. Meanwhile, C.R. Bard ($BCR) is studying its Lutonix balloon with an eye on the FDA two years after paying $225 million to get into the game, and Germany's Biotronik is developing a similar technology called Passeo-18 Lux.
IN.PACT Admiral is coated with a proprietary substance called FreePac, which couples an excipient with the common antirestenosis drug paclitaxel. The balloon has been CE marked since 2008.
- read Medtronic's announcement
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Editor's note: An earlier version of this story misstated how the device is implanted. We regret the error.