Covidien (NYSE:COV), a leading global provider of healthcare products, today released the results of the DEFINITIVE Ca++ study. DEFINITIVE Ca++ assessed the safety and effectiveness of the SilverHawk™ LS-C/TurboHawk™ Peripheral Plaque Excision Systems when used in conjunction with the SpiderFX™ Embolic Protection System to treat moderate to severely calcified lesions in the femoropopliteal artery. These calcified lesions are a form of Peripheral Arterial Disease (P.A.D.).
The study was reported by Daniel Clair, MD, Co-National Principal Investigator, Department Chair, Vascular Surgery, Cleveland Clinic, Lerner College of Medicine. Dr. Clair presented the study during the Proffered Papers / Late Breaking Trials Session at the International Symposium on Endovascular Therapy (ISET) Conference here.
The study confirmed difficult lesions can be treated safely and effectively with the TurboHawk and SpiderFX Devices. A total of 133 patients (168 lesions) were enrolled in this study. The degree of vessel narrowing was 76.5 percent and 80.0 percent of patients had compromised outflow at the time of the procedure. Severe calcification was noted in 81.0 percent of lesions and 17.9 percent were completely blocked. The rate of stent use was 4.1 percent. Per core laboratory assessment, the primary effectiveness endpoint (defined as less than or equal to 50.0 percent residual diameter stenosis) was achieved in 92.0 percent of lesions; per site assessment, it was achieved in 97.0 percent of lesions.
"The SpiderFX device was user-friendly and effective, and the TurboHawk device was very successful in tackling complex, calcified superficial femoral artery/popliteal disease," said David Roberts, MD, Co-National Principal Investigator, Medical Director of the Sutter Heart and Vascular Institute, Sutter Medical Center in Sacramento, CA. "The result was great, safe revascularization outcomes."
The 30-day freedom from major adverse event rate (MAE) was 93.1 percent, with no death, amputation, pseudo-aneurysm, or clinically-driven target vessel revascularization; three distal embolizations occurred and all three were treated without clinical sequelae. The data demonstrated a low 30-day MAE rate, a low bail-out stent rate, and a high rate of successful revascularization.
P.A.D. is one of the most common vascular diseases and occurs when leg arteries become narrowed or blocked by plaque. These blockages can result in severe leg pain for patients, limited physical mobility and non-healing leg ulcers. According to the American Heart Association, approximately 10 million people in the U.S. suffer from P.A.D.
"This study is just one aspect of the Covidien DEFINITIVE Trial Series, which is focused on demonstrating the efficacy of plaque excision as a safe and effective option in the treatment of P.A.D.," said Stacy Enxing Seng, President, Vascular Therapies, Covidien. "The results are promising in this large cohort of patients with advanced disease in challenging lesions."
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