FDA give 510(k) approval for Turbo Tandem/Elite ISR for PAD - Spectranetics
The FDA has given 510(k) clearance for peripheral atherectomy products, Turbo-Tandem and Turbo Elite, from Spectranetics, for the treatment of in-stent restenosis (ISR) in patients with Peripheral Artery Disease. FDA clearance comes on the heels of findings from the EXCITE ISR clinical study, the first multi-center, randomized prospective trial ever conducted for the treatment of ISR. It demonstrated highly superior safety and efficacy of laser atherectomy with adjunctive Percutaneous Transluminal Angioplasty (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.
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