Spectranetics Makes Pre-IDE Submission To FDA For The Treatment Of In-Stent Restenosis In The Legs
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Spectranetics Partnership (Nasdaq:SPNC) announced that it has made a pre-IDE (Investigational Device Exemption) submission to the Food and Narcotic Governance regarding the employ of laser ablation to treat in-stent restenosis (ISR) in the legs. ISR is caused by the re-growth of tissue within the stent, known as neointimal hyperplasia, which can guidance to blockages in the affected leg artery.
The pre-IDE submission makes reference to the results of bench testing associated with the interplay of laser and nitinol stents, which was formerly announced in a September 15, 2008 press release. This testing shows that stents subjected to lenghty 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 counsel from the peripheral artery ISR study PATENT, which is contemporary in Germany. Although the material from the PATENT check is preliminary, no evidence of stent damage has been observed during the procedure or during subsequent follow-up evaluations. Additionally, the utilize of laser coercion in ablating neointimal hyperplasia within restenosed stents has been acknowledged in the PATENT trial. To date, the percent thickness stenosis pre-treatment has been reduced from a niggardly of 87% to 30% publish laser in 39 subjects. The final residual stenosis after all treatment is 7%.
"We believe that the data we are submitting to FDA supports the safety and efficacy of laser ablation within nitinol stents," said Emile Geisenheimer, Chairman, Head of the state and Chief Executive Officer. "ISR remains a facund unmet need and, to our knowledge, no medical slogan nowadays is specifically cleared or approved by the FDA for the treatment of ISR in the legs. We believe there are almost 150,000 stents implanted annually above the knee, and clinical literature cites restenosis rates twelve months later the procedure ranging from 11% to 79%. Our mark this submission is to determine what, whether any, remaining steps may be required for FDA to grant clearance to bazaar our laser ablation products so that we can functioning to address this unmet need."
Spectranetics again said that in collaboration with VIVA Physicians, Inc., the agreement has been made to terminate the Recovery trial. Since this evaluation was not designed to result in FDA clearance, termination does not contact the just of obtaining FDA clearance for the use of laser ablation to treat ISR.
"Spectranetics values the befalling to cooperate with other production leaders on Salvation and appreciates the effort of all in this trial. It is important, however, that we bull's eye our clinical trial efforts on trials directed toward FDA clearance or approval," concluded Mister Geisenheimer.
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