Spectranetics Announces FDA Clearance of Peripheral Laser Atherectomy Devices for In-Stent Restenosis

The Spectranetics Corporation

today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance of their peripheral atherectomy products, Turbo-Tandem® and Turbo Elite®, for the treatment of in-stent restenosis (ISR). The clearance prompts a new standard of care in ISR treatment with improved clinical outcomes. "With mean lesion length at 20 centimeters, approximately one-third of the patients being re-treated for ISR and also approximately one-third with total occlusions, EXCITE represents a very sick, real-world patient set," said Eric Dippel, MD, of Genesis Heart Institute in Davenport, Iowa. "The highly superior outcomes for both safety and efficacy and the delta in procedural success rates between the two arms of the trial are compelling. Given that a significant number of patients today are treated with PTA alone with very poor outcomes, EXCITE demonstrates a proven treatment algorithm that physicians and their patients need." "FDA clearance of our peripheral atherectomy devices to treat ISR is a landmark moment for Spectranetics and patients worldwide," said Scott Drake, President and CEO of Spectranetics. "We are the only company with indicated devices, our primary competitors are contraindicated; we possess clinical data that will change clinical practice and a scaled commercial team to capitalize on this $750 million market opportunity." FDA clearance 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 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 PTA compared with PTA alone. The trial shows a 94% procedural success rate using laser atherectomy with PTA versus 83% 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 Percutaneous Transluminal Angioplasty (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% 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 United States, Spectranetics is uniquely positioned to capitalize on potential market opportunities of $350 million domestically and up to $750 million worldwide.