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.
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."
The 2 trials that launched this week are part of a series of 4 trials for Stellarex, including a European trial and a global trial currently enrolling patients.
This month, the company finalized the spin-out of its pharmaceutical business by announcing the launch of Mallinckrodt plc (NYSE:MNK) on the New York Stock Exchange.