Spectranetics Corporation11.13.15
Colorado Springs, Colo.-based Spectranetics Corporation has earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for 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, M.D., 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 a large, multicenter, prospective randomized trial. 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:
In July 2014, Spectranetics received FDA 510(k) indication for 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.
Over 200 million people worldwide are afflicted with peripheral arterial disease and prevalence has grown over 25 percent in the last decade. Among the 25 million people in the United States and Europe alone, only about 1.5 million procedures are performed annually, with a third of these patients undergoing costly bypass surgery or, tragically, amputation.
Implanting stents to open obstructed blood vessels is an important treatment for patients suffering from peripheral arterial disease. While stents deliver improved overall outcomes compared to percutaneous transluminal angioplasty treatment, restenosis (a return of the blockage) is very common, and in-stent restenosis or ISR remains therapeutically challenging. Once ISR develops, there is a 65 percent chance of recurrence after treatment with PTA. PTA, also known as balloon angioplasty, is considered the current standard of care. Over 115,000 ISR procedures are performed annually in the United States.
Spectranetics makes minimally invasive medical devices for the cardiovascular system.
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, M.D., 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 a large, multicenter, prospective randomized trial. 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 rates at 30 days 5.4 percent vs. 20.8 percent with PTA alone; and
- Primary efficacy endpoint, freedom from target lesion revascularization through six months 78.3 percent vs. 58.9 percent with PTA alone.
In July 2014, Spectranetics received FDA 510(k) indication for 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.
Over 200 million people worldwide are afflicted with peripheral arterial disease and prevalence has grown over 25 percent in the last decade. Among the 25 million people in the United States and Europe alone, only about 1.5 million procedures are performed annually, with a third of these patients undergoing costly bypass surgery or, tragically, amputation.
Implanting stents to open obstructed blood vessels is an important treatment for patients suffering from peripheral arterial disease. While stents deliver improved overall outcomes compared to percutaneous transluminal angioplasty treatment, restenosis (a return of the blockage) is very common, and in-stent restenosis or ISR remains therapeutically challenging. Once ISR develops, there is a 65 percent chance of recurrence after treatment with PTA. PTA, also known as balloon angioplasty, is considered the current standard of care. Over 115,000 ISR procedures are performed annually in the United States.
Spectranetics makes minimally invasive medical devices for the cardiovascular system.