Regulators in Europe handed Stentys SA (EPA:STNT) expanded indications for its self-apposing stent, opening up new potential patient populations.
The Stentys treatment for acute myocardial infarction can now be used in patients with trickier cases, such as those with tapered, dilated or very large vessels or those with bypass grafts. E.U. healthcare regulators also lifted certain contraindications on the device, such as for chronic total occlusions and left main bifurcations.
Princeton, N.J.- and Paris-based Stentys says the new indications allow the medical device company to market its device to a patient group that represents about 10% of all percutaneous coronary interventions in Europe.
CEO and co-founder Gonzague Issenmann said the company is looking to push beyond the traditional heart attack market in Europe, according to prepared remarks.
"Our European customers are using the Stentys Self-Apposing Stent for their patients with atypical vessel anatomies because this is the only available product that solves this unmet need," he said in the statement.
Stentys is hoping a new U.S. clinical trial called Apposition V will help it win pre-market approval for the self-apposing coronary stent.
