Spectranetics Submits 510(k) Application To Food And Drug Administration Seeking Clearance For The Treatment Of In-Stent Restenosis In The Legs

Main Category: Vascular
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 01 Oct 2009 - 1:00 PDT

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Spectranetics Corporation (Nasdaq: SPNC) announced that it has filed a 510(k) application with the Food and Drug Administration seeking clearance for the treatment of in-stent restenosis (ISR) in the legs with its commercially available peripheral atherectomy products. ISR is caused by the re-growth of tissue within the stent, known as neointimal hyperplasia, which can lead to blockages in the affected leg artery.

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 following laser interaction had no fatigue-related failures. The submission also includes 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 submission of our 510(k) application follows close consultation and cooperation with the FDA to identify the appropriate regulatory path. We look forward to the FDA's review and stand ready to address any remaining questions or concerns they may have," said Emile J. Geisenheimer, Chairman, President and Chief Executive Officer.

Source
Spectranetics