Spectranetics peripheral laser atherectomy devices receive FDA approval for in-stent restenosis

July 29, 2014

Spectranetics, an excimer laser maker, has received FDA approval for its Turbo-Tandem and Turbo Elite peripheral laser atherectomy products to treat in-stent restenosis (ISR).

Spectranetics (Colorado Springs, CO), an excimer laser maker, has received FDA approval for its Turbo-Tandem and Turbo Elite peripheral laser atherectomy products to treat in-stent restenosis (ISR). The clearance prompts a new standard of care in ISR treatment with improved clinical outcomes.

The approval comes on the heels of the EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal (the arteries above and behind the knee) In-Stent Restenosis (EXCITE ISR) clinical findings. The study, which is said to be the first multi-center, randomized prospective trial ever conducted for the treatment of ISR, demonstrated highly superior safety and efficacy of laser atherectomy with adjunctive percutaneous transluminal angioplasty (PTA) compared with PTA alone. The trial shows a 94-percent procedural success rate using laser atherectomy with PTA vs. 83 percent with PTA alone.

Notably, the average lesion length was approximately 20 cm as compared to various stent IDE studies with average lesion lengths of 4 to 6 cm. Additionally, a high number of complex or advanced disease-state patients were enrolled in the trial, indicative of success in treating all types of ISR lesions, including the most complex cases. Complete results from the EXCITE trial have been submitted to a peer-reviewed medical journal.

Implanting stents to open obstructed blood vessels is an important treatment for patients suffering from peripheral artery disease (PAD). While stents deliver improved overall outcomes compared to PTA treatment, restenosis (a return of the blockage) is very common, and stent re-obstruction 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. With over 115,000 ISR procedures performed annually in the U.S., the company is positioned to capitalize on potential market opportunities of $350 million domestically and up to $750 million worldwide.