Medtronic Takes on PAD Balloon Market

Medtronic is on the way to FDA approval of its novel drug-eluting balloon. This week, the company submitted the first module of its application, aiming for commercialization by 2015.

The new device, dubbed IN.PACT Admiral, is designed for the treatment of superficial femoral artery (SFA) atherosclerotic lesions in a patient's arteries. The company is taking a modular approval path while it works with regulators.

In total, the clinical program comprises 4,200 patients and 24 separate studies. While the company may be leading the market with its novel drug-eluting balloon for now, it faces tough competition from rivals.

Earlier in 2013, Covidien paid CV Ingenuity for a peripheral artery disease balloon. This spring, Covidien presented one-year data at EuroPCR, reporting 87% primary patency in a patient's treated arteries. The company also reported no amputations or deaths as a result of the device. In addition, CR Bard is currently developing its Lutonix balloon, hoping to get FDA approval. This follows Bard's entry into the PAD balloon market two years ago. On top of this, Biotronik is engineering a related system, dubbed Passeo-18 Lux.

"Pending FDA approval, we remain on track to launch the IN.PACT Admiral drug-eluting balloon in the United States during the second half of calendar year 2015," stated Tony Semedo, president of Endovascular Therapies at Medtronic. "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."