Two-Year ILLUMENATE FIH Data Presented for Covidien's Stellarex DCB

May 22, 2014—Covidien announced the presentation of 24-month data from the company’s ILLUMENATE first-in-human (FIH) study of the Stellarex drug-coated balloon (DCB) at the EuroPCR 2014 congress being held May 20 to 23 in Paris, France. The data indicate that the Stellarex DCB continues to be shown as safe and effective for treatment of peripheral arterial disease (PAD). The Stellarex DCB, which uses Covidien’s EnduraCoat balloon coating technology, is designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site, according to the company.

The ILLUMENATE FIH study is a prospective, multicenter, single-arm study designed to assess the safety and effectiveness of the Stellarex DCB. In the study, 58 superficial femoral and/or popliteal lesions in 50 patients were predilated with an uncoated angioplasty balloon, followed by treatment with the Stellarex DCB. The Stellarex DCB is intended to treat lesions in leg arteries by opening the occluded vessels, restoring blood flow, and delivering paclitaxel to the vessel wall.

The study found the Stellarex DCB to be safe, with durable results to 24 months, and a primary patency of 82.3%; no reported amputations or cardiovascular deaths; and an 87.9% rate of freedom from clinically driven target lesion revascularization. This is the same rate observed at 12 months, with no new events reported, demonstrating a sustained low rate of repeat treatment out to 24 months. Covidien advised it is conducting additional large clinical trials to further validate the FIH findings.

“We are very pleased with the study’s promising results, as they support the use of an important emerging treatment for a painful and physically limiting condition that affects millions of people around the world,” commented the study’s Principal Investigator, Henrik Schröder, MD, in the company’s press release. Dr. Schröder, who is a radiologist at the Vascular Center-Jewish Hospital in Berlin, Germany, added, “Good patency after 2 years, which translated into the absence of new clinically driven target lesion revascularizations after 1 year and through the second year patient follow-up, demonstrates the durability of the Stellarex drug-coated angioplasty balloon.”