Spectranetics Corporation today announced that it has made a pre-Investigational Device Exemption submission to the Food and Drug Administration (FDA) regarding the use of laser ablation to treat in-stent restenosis in the legs.
The pre-Investigational Device Exemption submission 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 in-stent restenosis and an analysis of interim data from the peripheral artery in-stent restenosis 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. Additionally, the application of laser energy in ablating neointimal hyperplasia within restenosed stents has been successful in the PATENT trial. To date, the percent diameter stenosis pretreatment has been reduced from a mean of 87% to 30% post-laser in 39 subjects. The final residual stenosis after all treatment is 7%.
“We believe that the data we are submitting to the FDA supports the safety and efficacy of laser ablation within nitinol stents,” said Emile Geisenheimer, Chairman, President and Chief Executive Officer of Spectranetics.
“In-stent restenosis remains a significant unmet need and, to our knowledge, no medical device today is specifically cleared or approved by the FDA for the treatment of in-stent restenosis in the legs. We believe there are nearly 150,000 stents implanted annually above the knee, and clinical literature cites restenosis rates twelve months following the procedure ranging from 11% to 79%. Our objective through this submission is to determine what, if any, remaining steps may be required for the FDA to grant clearance to market our laser ablation products so that we can work to address this unmet need.