ILLUMENATE first-in-man study shows promising results with Covidien’s new drug-eluting balloon


Twelve-month results from the ILLUMENATE First-in-Human Study on the safety and effectiveness of Covidien’s drug-eluting balloon were presented at the EuroPCR congress in Paris, France. The new platform features a paclitaxel-coated angioplasty balloon with a proprietary, rapid-release drug delivery mechanism.

This European FIH study is a prospective, controlled, multicentre study of 50 subjects with lesions in the superficial femoral and/or popliteal arteries. A total of 58 lesions (up to 15cm in length) in vessels 3-7mm in diameter were treated with the Covidien drug-coated peripheral angioplasty balloon. Patients were evaluated at one, six, and 12 months following the procedure. Lesions were evaluated angiographically at six months and by duplex ultrasound at six and 12 months.

“This was a well-designed study with a high level of clinical rigor,” said Stephan Duda, interventional radiologist, Vascular Center-Jewish Hospital, Berlin, Germany, who presented the study results at EuroPCR. “Clinical events were adjudicated by an independent physician clinical events committee, and results were validated by independent angiographic and sonographic core laboratories. Because of this, I believe that the study results to date indicate that this is a safe device with durability out to 12 months.”

Primary patency was 87% at the 12-month effectiveness endpoint of this study. This was evaluated by Kaplan-Meier analysis using a duplex ultrasound peak systolic velocity ratio (PSVR) of ≤2.5. Incidence of major adverse events, the study’s safety endpoint, was 4% at six months (no deaths, no amputations and two target lesion revascularisations) and 10% (no deaths, no amputations and five target lesion revascularisations) at 12 months.