The Spectranetics Corporation today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance of its peripheral atherectomy product, the Turbo-Power™ Laser Atherectomy Catheter, for the treatment of in-stent restenosis (ISR). Laser atherectomy is driving a new standard of care for in-stent restenosis treatment with improved clinical outcomes and products that evolve to meet patient and physician needs.
Uniquely designed to optimize ISR treatment, the Turbo-Power™ Laser Atherectomy Catheter treats 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.
"Patients with ISR present the most challenging real-world cases, with the longest, toughest lesions, among those suffering with peripheral arterial disease," said Craig Walker, MD, 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. "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 six months. With proven evidence, Turbo-Power will clearly drive practice adoption and set a new standard of care in ISR treatment."
The EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal (arteries above the knee) In-Stent Restenosis (EXCITE ISR) is the first of its kind, large multicenter, prospective randomized trial ever conducted for the treatment of FemPop ISR. Durable results show that Spectranetics' laser atherectomy devices used with PTA (also known as balloon angioplasty) are safer and more effective than PTA alone for treating FemPop ISR based on two key data 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 revascularization (TLR) through six months 78.3% vs. 58.9% with PTA alone (p=0.002).
"With a relentless focus on improving patient care, Spectranetics is pleased to bring Turbo-Power, the next-generation in-stent restenosis treatment solution, to market, providing physicians and their patients a new standard of care they seek and deserve," said Shar Matin, Chief Operating Officer, Spectranetics. "As the only company with a FemPop in-stent restenosis indication, backed by Level 1 clinical evidence, and primary competitors contraindicated or not indicated, we are well positioned to deliver tools that advance care for patients suffering from peripheral arterial disease."
In July 2014, Spectranetics received FDA 510(k) indication of its peripheral atherectomy products, Turbo-Tandem™ and Turbo-Elite™, to treat ISR. This next-generation tool, the Turbo-Power™ Laser Atherectomy Catheter, is optimized to treat ISR and capitalize on the original indication, enhancing Spectranetics' comprehensive portfolio to cross, prep and treat the most complex cardiovascular conditions.