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September 28, 2009
Spectranetics Seeks Device Clearance to Treat ISR in Legs
September 29, 2009—Spectranetics Corporation (Colorado Springs, CO) announced that the company has filed a 510(k) application with the US Food and Drug Administration seeking clearance for the treatment of in-stent restenosis (ISR) in legs with its commercially available peripheral atherectomy products.
According to the company, the 510(k) application makes reference to the results of bench testing associated with the interaction of laser and nitinol stents. This testing shows that stents subjected to extensive fatigue testing after laser interaction had no fatigue-related failures. The submission also includes a reference to clinical data supporting the safety and efficacy of excimer laser treatment in coronary artery ISR and an analysis of interim data from the peripheral artery ISR study, PATENT, which is ongoing in Germany. Although the data from the PATENT trial is preliminary, no evidence of stent damage has been observed during the procedure or during subsequent follow-up evaluations, the company stated.
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