Stentys calls its suite of Apposition stents the "world’s 1st and only self-apposing stent to treat acute myocardial infarction," with a shape and size that adapts to "fit snugly" into blood vessels to prevent gaps that can lead to blood clots.
"Long-term malapposition of drug-eluting stents has been associated with late stent thrombosis, so this randomized trial with the new Stentys sirolimus-eluting self-apposing stent will be carefully followed by the community," co-principal investigator Dr. William Wijns said in prepared remarks. Wijns is also chairman of the European Assn. of Percutaneous Cardiovascular Interventions.
The Princeton, N.J.-based company will enroll 150 heart attack patients into a randomized, multi-center study will follow-up at 4 and 9 months.
Stentys expects to complete trial enrollment before the end of the year, with results available by the 2nd half of 2013 and CE Mark approval in the European Union in the 2nd half of 2014, according to a press release.
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