PARIS--(Covidien, a leading global provider of healthcare products, announced the 12-month results from its ILLUMENATE First-in-Human (FIH) Study on the safety and effectiveness of Covidien’s advanced drug-coated balloon (DCB) technology at the EuroPCR Scientific Congress here. The new platform, featuring a paclitaxel-coated angioplasty balloon with a proprietary, rapid-release drug delivery mechanism, is designed to treat blockages in leg arteries caused by peripheral arterial disease (PAD).)--
“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.”
This European FIH study is a prospective, controlled, multi-center study of 50 subjects with lesions in the superficial femoral and/or popliteal arteries. A total of 58 lesions (up to 15 cm in length) in vessels 3-7 mm in diameter were treated with the Covidien drug-coated peripheral angioplasty balloon. Patients were evaluated at 1, 6, and 12 months following the procedure. Lesions were evaluated angiographically at 6 months and by duplex ultrasound at 6 and 12 months.
"This was a well-designed study with a high level of clinical rigor," said Prof. Stephan Duda, MD, Radiologist, Vascular Center-Jewish Hospital, Berlin, Germany, who delivered the study results at the EuroPCR Congress. “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."
ILLUMENATE FIH 12-Month Effectiveness and Safety Results
Primary patency (defined as the treated artery remaining patent without any re-treatment) 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 (MAE), the study’s safety endpoint, was 4% at 6 months (no deaths, no amputations and 2 target lesion revascularizations) and 10% (no deaths, no amputations and 5 target lesion revascularizations) at 12 months.
“We are very pleased with the promising safety and effectiveness 12-month results from our ILLUMENATE FIH study,” said Mark A. Turco, MD, Chief Medical Officer, Vascular Therapies, Covidien. “We will continue to commit resources to the ILLUMENATE clinical program, providing more clinical evidence around our DCB technology in the hopes of delivering the best treatment and technology for patients suffering from PAD.”
Additional large clinical trials are planned by Covidien to further validate these first-in-human results.
About the Disease, Product and Procedure
PAD is one of the most common vascular diseases and occurs when leg arteries become narrowed or blocked by plaque and compromise blood flow. This condition can result in severe pain, limited physical mobility and non-healing leg ulcers, and can potentially lead to amputation. PAD currently affects an estimated 27 million adults in Europe and North America.1
When PAD causes symptoms in patients, blockages may need to be treated to restore blood flow to the legs and feet. Treatment options include angioplasty, a procedure in which a balloon catheter is delivered to the blockage and the balloon expanded to re-open the blood vessel. Re-blockage following an angioplasty remains a challenge and can occur in up to 50% of patients within 12 months of treatment, depending on the length and complexity of the blockage.2
The Covidien drug-coated peripheral angioplasty balloon provides the same mechanical effect of opening the vessel with the added advantage of drug delivery. When expanded, the balloon also rapidly deposits the drug paclitaxel into the vessel wall to inhibit re-blockage. This treatment is designed with the potential to lengthen the clinical durability of angioplasty treatment, while leaving nothing behind (e.g., stent) in the blood vessel.
- Belch JJ, Topol EJ, Agnelli G, et al. Critical issues in peripheral arterial disease detection and management: a call to action. Arch Intern Med. Apr 28 2003;163(8):884-892.
- Laird et al. Nitinol Stent Implantation Versus Balloon Angioplasty for Lesions in the Superficial Femoral Artery and Proximal Popliteal Artery: Twelve-Month Results From the RESILIENT Randomized Trial Circ Cardiovasc Interv. 2010;3: 267-276.