Spectranetics has reported that its peripheral atherectomy device—the Turbo-Power laser atherectomy catheter—has received US Food and Drug Administration (FDA) 510(k) clearance for the treatment of in-stent restenosis (ISR).
The Turbo-Power device uses vaporising technology to treat at the trip, designed to optimise luminal gain. According to Spectranetics, the product debulks lesions in one step, and offers remote automatic rotation for precise directional control.
Craig Walker, president and medical director, Cardiovascular Institute of the South; clinical professor of medicine, Tulane University and Louisiana State University Medical Schools; and chairman, New Cardiovascular Horizons, says “Turbo-Power allows effective de-bulking of ISR lesions. The device is backed by Level 1 clinical data proving both safety and efficacy at six months.”
The Excimer laser randomised controlled study for treatment of femoropopliteal in-stent restenosis (EXCITE ISR) is a large, multicentre, prospective randomised trial conducted for the treatment of femoropopliteal ISR.
Results show that Spectranetics’ laser atherectomy devices used with balloon angioplasty are safer and more effective than balloon angioplasty alone for treating femoropopliteal ISR based on two key findings:
- Primary safety endpoint, major adverse events (MAEs) rates at 30 days 5.4% vs. 20.8% with PTA alone (p<0.001).
- Primary efficacy endpoint, freedom from target lesion revascularisation (TLR) through six months 78.3% vs. 58.9% with PTA alone (p=0.002).