At the study’s final 3-year mark 78.5% patients did not need clinically driven target lesion revascularization, and the stent fracture rate remained low at 3.6% with all reported fractures labeled Type I, the least severe, according to a press release.
“We are very pleased that patients continue to feel better 3 years after treatment with the S.M.A.R.T. Stent," Cordis president Celine Martin said in prepared remarks. "We are continuing to build on the legacy of this exceptional platform with our next generation S.M.A.R.T. Flex Stent and look forward to delivering future innovations in self-expanding stents for patients suffering from peripheral artery disease."
The Bridgewater, N.J.-based medical device company makes less invasive treatment options for vascular disease. The S.M.A.R.T. stent is a smaller stent that can still minimize vessel prolapse while conducting the strength of blood flow.
The STROLL trial is a multi-center, non-randomized, single-arm prospective trial comparing the S.M.A.R.T. vascular stent systems against a published performance goal.
The new results come almost exactly 1 year to the day after Cordis reported its 2-year outcomes, at which time the company touted freedom from clinically driven target revascularization at 2 years in more than 80% of enrolled patients, nearly half of which were diabetic and nearly a quarter of which entered the trial with total occlusions.
Cordis is waiting to hear where stent pioneer Dr. Bruce Saffran appeal to the U.S. Supreme Court goes, in connection to the company’s recent $600 million patent infringement win. Saffran alleged that Cordis violated his patent with its Cypher drug-eluting stent, in a case he won. Nonetheless, last April the U.S. Court of Appeals for the Federal Circuit overturned the infringement ruling, on the grounds that the lower court’s claim construction was wrong.