FDA Clears Spectranetics' Turbo-Power Laser Atherectomy Catheter to Treat ISR

November 12, 2015—The Spectranetics Corporation announced it has received US Food and Drug Administration (FDA) 510(k) clearance for the Turbo-Power, a laser atherectomy catheter for the treatment of in-stent restenosis (ISR) in peripheral arteries.

According to the company, the Turbo-Power catheter is designed to treat at the tip with vaporizing technology for maximal luminal gain. The device debulks the lesion in a single step and offers remote automatic rotation for precise directional control. The Turbo-Power is Spectranetics’ next-generation peripheral atherectomy device for the treatment of ISR after the Turbo-Tandem and Turbo-Elite devices, which received FDA clearance for this indication in July 2014.

Spectranetics noted that durable results from EXCITE ISR, the Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis, show that Spectranetics’ laser atherectomy devices, when used with percutaneous transluminal angioplasty (PTA), are safer and more effective than PTA alone for treating femoropopliteal ISR. The two key findings from the large multicenter, prospective, randomized EXCITE ISR trial are the primary safety endpoint of the rate of major adverse events at 30 days (5.4% vs 20.8% with PTA alone; P < .001) and the primary efficacy endpoint of the rate of freedom from target lesion revascularization at 6 months (78.3% vs 58.9% with PTA alone; P = .002), reported Spectranetics.

In Spectranetics’ press release, Craig Walker, MD, commented, “Patients with ISR present the most challenging real-world cases, with the longest, toughest lesions among those suffering with peripheral artery disease. Turbo-Power, with its eccentric tip design, allows far more effective debulking of ISR lesions, and I am optimistic the tool will further improve outcomes for patients. The device is backed by level 1 clinical data proving both safety and efficacy at 6 months. With proven evidence, Turbo-Power will clearly drive practice adoption and set a new standard of care in ISR treatment.” Dr. Walker is President and Medical Director of the Cardiovascular Institute of the South in Louisiana; Clinical Professor of Medicine, Tulane University and Louisiana State University Medical Schools; and Chairman, New Cardiovascular Horizons.