Covidien launches 2 trials to support its Stellarex drug-device combo

July 17, 2013 by Sony Salzman

Covidien begins enrollment in a pair of clinical studies evaluating its Stellarex drug-coated angioplasty balloon in the U.S. and abroad.

Covidien launched 2 trials to support its Stellarex drug-device combo

Covidien (NYSE:COV) kicked off 2 new clinical trials this week to support a global evaluation of its Stellarex drug-coated angioplasty balloon.

The Massachusetts-based company started enrolling patients with peripheral arterial disease in the Pivotal and PK arms of its larger ILLUMENATE clinical trials examining the safety and effectiveness of Covidien's Stellarex devices.

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Both the PK and Pivotal study will evaluate the Stellarex balloon in treatment of de novo blockages or re-blockage of the superficial femoral or popliteal arteries, according to a company press release. The PK study will enroll up to 25 patients, with 1st enrollment taking place in New Zealand. The Pivotal arm will enroll up to 360 patients in the U.S.

Peripheral arterial disease occurs when plaque builds up in the leg arteries, a condition affecting more than 10 million people in the U.S., according to Covidien. The device has not hit shelves in the States, but the FDA granted investigational device exemption so that Covidien can move forward with its clinical trials.

"The ILLUMENATE clinical trial program demonstrates Covidien's commitment to provide evidence-based treatment options for physicians and their patients who suffer from PAD," said CMO Dr. Mark Turco in prepared remarks. "Robust clinical evidence is critical in enabling physicians to make the best possible treatment decisions and achieving the best outcomes for their patients."