|Covidien Releases Clinical Data on Plaque Excision for the Treatment of Calcified Lesions|
Final Results from DEFINITIVE Ca++ Clinical Study Presented at ISET 2012
The study was reported by
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
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
“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