Covidien's (COV -0.4%) drug-coated angioplasty balloon, Stellarex DCB, continues to demonstrate its safety and effectiveness as a treatment for peripheral arterial disease (PAD) in a 24-month clinical study titled ILLUMINATE FIH.
58 superficial femoral and/or popliteal lesions in 50 patients were pre-dilated with an uncoated angioplasty balloon followed by treatment with the Stellarex DCB. The company's product opens occluded blood vessels and simultaneously delivers paclitaxel to the vessel wall to help prevent restenosis.
Primary patency (the treated artery remained open without further treatment) was 82.3% at 24 months. Freedom from clinically-driven lesion revascularization at 24 months was 87.9%. This was the same rate observed at 12 months. No amputations or cardiovascular deaths were reported.
Covidien scientists presented the FIH study results at the EuroPCR Scientific Congress in Paris this week.