According to a recent press release, Colorado Springs-based Spectranetics announced that it has received FDA 510(k) clearance for its Turbo-Power™ Laser Atherectomy Catheter, a peripheral atherectomy product used to treat in-stent restenosis (ISR). The press release notes that ISR is a $350 million domestic and $750 million global market.
According to the press release, 1.5 million procedures are performed annually to treat peripheral arterial disease, which affects 200 million people worldwide (approximately 10 million in the U.S. alone). Between two of the several procedures used to treat this disease, “stents deliver improved overall outcomes compared to Percutaneous Transluminal Angioplasty,” otherwise known as balloon angioplasty. However, after a stent has been implanted to clear an obstructed blood vessel, the blockage can return, resulting in an ISR. The press release further notes that balloon angioplasty, the current standard of ISR treatment, suffers from a 65% ISR recurrence rate.
The press release further states that as demonstrated by the EXCITE ISR randomized trial for the treatment of Femoropopliteal (FemPop) ISR, Spectranetics’ laser atherectomy devices, when used in combination with balloon angioplasty, are significantly safer and more effective than balloon angioplasty alone. Specifically, the EXCITE ISR trial reported that the combination treatment had a major adverse event (MAE) rate at 30 days of 5.4% and a freedom from target lesion revascularization through six months rate of 78.3%, compared to rates of 20.8% and 58.9%, respectively, for balloon angioplasty alone.
Dr. Craig Walker, President and Medical Director of the Cardiovascular Institute of the South, Clinical Professor of Medicine at the Tulane University and Louisiana State University Medical Schools, and Chairman of New Cardiovascular Horizons, stated
“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.”
According to Spectranetics, the Turbo-Power™ Laser Atherectomy Catheter is the latest in Spectranetics’ “comprehensive portfolio to cross, prep and treat the most complex cardiovascular conditions.” It is also stated to be the “next-generation tool” in ISR treatment, building on prior peripheral atherectomy products Turbo-Tandem™ and Turbo-Elite™, which received 510(k) clearance in July 2014.
Shar Matin, Chief Operating Officer of Spectranetics, stated:
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.
According to its website, Spectranetics is a medical device company which develops minimally invasive products “used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.”