Spectranetics is initiating a new clinical trial to evaluate treatment of in-stent restenosis (ISR) in arteries above the knee. There is no device currently approved by the FDA to treat ISR.
The Colorado Springs, Colo.-based company plans to initiate a multi-center, randomized trial in the U.S. comparing laser ablation followed by adjunctive balloon angioplasty with balloon angioplasty alone.
The trial, which was originally designed as a feasibility trial, will be made once the FDA has completed its review of the company's pre-IDE submission for the U.S. randomized, controlled two-arm trial. Until then, enrollments will continue in PATENT, which currently has 66 patients enrolled in five centers in Germany.
“The trial is seeking to evaluate the safety and effectiveness of the Turbo-Tandem and our Turbo Elite laser ablation devices," Emile J. Geisenheimer, Spectranetics' chairman of the board of directors, president and CEO, said in an interview. “We are hypothesizing that laser ablation followed by adjunctive balloon angioplasty could lead in a durable result.”
“ISR is a difficult, unsolved problem, especially in the superficial femoral artery,” he said. “Based on the current literature, most people believe that stenting leads to ISR about 30-40 percent of the time; also there is a subset of patients who have recurring restenosis. While balloons have been used to address this concern, there is a need for new technologies.”