Spectranetics Corporation has stopped enrolling patients in the air max 270 homme CELLO study after enrolling 61 of the planned 85 patients. Based on a review of the preliminary data, Spectranetics and FDA agreed that the clinical data from these 61 patients treated with the TURBO-Booster product is sufficient for submission to FDA for review. The follow-up data is expected to be gathered early in the second quarter of 2007 and the 510(k) application is currently expected to be filed with FDA later in the second quarter of 2007.
The TURBO-Booster is a deflecting sheath that treats blockages in the superficial femoral artery – the main artery above the knee. The device is used with Spectranetics’ existing TURBO elite laser catheters.
The CELLO trial was initiated in July 2006 and enrolled patients with air max 270 homme blockages above the knee ranging in length from 1 centimeter to 15 centimeters. The primary endpoint of the trial included angiographic core lab measurements of the percent reduction in the size of the blockage following laser treatment. Additional clinical endpoints included 30-day patency using core lab evaluated duplex ultrasound, improvements in ankle-brachial index, and walking impairment improvement at 30 days post-procedure.
“Completion of the CELLO trial has been our top priority since the air max 270 homme trial began nine months ago and we are pleased that we have concluded enrollment in the trial ahead of our own expectations,” said John G. Schulte, Spectranetics’ president and CEO.
Two-thirds of the estimated 400,000 endovascular procedures performed annually in the United States are done on above-the knee blockages.http://www.sneaker2018.fr/