France's Stentys anticipates a CE mark for its sirolimus-eluting stent as soon as the second half of 2014 due to the results of its three clinical trials released May 27 in a late-breaking session of the EuroPCR conference in Paris.
The company touted the results of its 9-month Apposition IV trial, which compares the product to Medtronic's ($MDT) Resolute stent via optical coherence tomography. "The sirolimus-eluting Self-Apposing stent (SES) demonstrated excellent efficacy compared to market leading stents and faster healing compared to balloon-expandable stents," the company said in a statement that did not contain any specific data from the trial.
Four-month data described on the company's website found that 32% of the SES had all of their struts covered compared to 4% of the balloon-expandable stents.
The company also cited 6-month data from the Adept clinical trial, which it says showed that its self-apposing stent is well suited to treat diseased bypass grafts. That stent received a CE mark in 2010, according to the statement.
Stentys also said its paclitaxel-eluting stent is effective for treating coronary bifurcation narrowing. The rate of major adverse cardiac events was 12.6% after 12 months in the Open II trial. The company said in the statement that the rate is similar to the results from other trials.
Based in Princeton, NJ, and Paris, Stentys recently disclosed an operating loss of €11.98 million ($16.63 million) on €3.39 million ($4.7 million) in 2013 revenue.
- read the release