The Spectranetics Corporation has announced receiving US FDA 510(k) clearance of their peripheral atherectomy products, Turbo-Tandem and Turbo Elite, for the treatment of in-stent restenosis.
FDA clearance comes on the heels of the EXCITE ISR (Excimer laser randomised controlled study for treatment of femoropopliteal in-stent restenosis) study’s clinical findings. The study, which is the first multicentre, randomised, prospective trial conducted for the treatment of in-stent restenosis, demonstrated highly superior safety and efficacy of laser atherectomy with adjunctive percutaneous transluminal angioplasty compared with angioplasty alone. The trial shows a 94% procedural success rate using laser atherectomy with angioplasty versus 83% with angioplasty alone.
“With mean lesion length at 20cm, approximately one-third of the patients being re-treated for in-stent restenosis and also approximately one-third with total occlusions, EXCITE represents a very sick, real-world patient set,” said Eric Dippel, Genesis Heart Institute, Davenport, USA. “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 percutaneous transluminal angioplasty alone with very poor outcomes, EXCITE ISR demonstrates a proven treatment algorithm that physicians and their patients need.”
A press release from the company notes that the average lesion length was approximately 20cm in EXCITE ISR as compared to various stent investigational device exemption studies with average lesion lengths of 4–6cm. Additionally, a high number of complex or advanced disease-state patients were enrolled in the trial, indicative of success in treating all types of lesions, including the most complex cases. Complete results from the EXCITE trial have been submitted to a peer-reviewed medical journal, the release states.