On 23 January, Covidien released the results of the DEFINITIVE Ca++ study which assessed the safety and effectiveness of the SilverHawk LS-C and 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.
The study was presented by Daniel Clair, co-national principal investigator, department chair, Vascular Surgery, Cleveland Clinic, Lerner College of Medicine, Clevaland, USA, during the Proffered Papers / Late Breaking Trials Session at the International Symposium on Endovascular Therapy (ISET) in Miami, USA.
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% and 80.0% of patients had compromised outflow at the time of the procedure. Severe calcification was noted in 81% of lesions and 17.9% were completely blocked. The rate of stent use was 4.1%. Per core laboratory assessment, the primary effectiveness endpoint (defined as less than or equal to 50% residual diameter stenosis) was achieved in 92% of lesions; per site assessment, it was achieved in 97% 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, co-national principal investigator, medical director of the Sutter Heart and Vascular Institute, Sutter Medical Center in Sacramento, California, USA. “The result was great, safe revascularisation outcomes.”
The 30-day freedom from major adverse event rate (MAE) was 93.1%, with no death, amputation, pseudo-aneurysm, or clinically-driven target vessel revascularisation; 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 revascularisation.