Spectranetics Files Pre-IDE FDA for Treatment of In-Stent Restenosis in the Legs
May 6, 2009 - Spectranetics Corp. yesterday said it made a pre-IDE (investigational device exemption) submission to the FDA regarding the use of laser ablation to treat in-stent restenosis (ISR) in the legs.
ISR is caused by the regrowth of tissue within the stent, known as neointimal hyperplasia, which can lead to blockages in the affected leg artery.
The pre-IDE submission makes reference to the results of bench testing associated with the interaction of laser and nitinol stents, which showed 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, the company said 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 pre-treatment has been reduced from a mean of 87 to 30 percent post laser in 39 subjects. The final residual stenosis after all treatment is 7 percent.
Spectranetics also said in collaboration with VIVA Physicians Inc., the decision was made to terminate the SALVAGE trial. Since this trial was not designed to result in FDA clearance, termination does not impact the objective of obtaining FDA clearance for the use of laser ablation to treat ISR.
Spectranetics manufactures and markets the only Excimer Laser System approved in the U.S., Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system. More than 800 Spectranetics laser systems are used in hospitals worldwide, the company said.
The company’s vascular intervention products include a range of peripheral and cardiac laser catheters for ablation of occluded arteries above and below the knee and within coronary arteries. The company also markets aspiration catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages. The lead management product line includes excimer laser sheaths and cardiac lead management accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information visit www.spectranetics.com