STENTYS Self-Apposing Stent Approved in Europe for Additional Coronary Indications
-- New market segments represent 10% of all coronary interventions
PRINCETON, N.J. & PARIS. -- STENTYS, a medical technology company commercializing in Europe the world's first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), announced today that it received approval from its European Notified Body to expand the CE Mark indications of the Self-Apposing stent.
Patients suffering from chronic chest pain due to narrowed coronary arteries are often treated with a stent. Coronary arteries generally have cylindrical shape and uniform diameters, but in some patients, arteries vary greatly in diameter and conventional stents cannot maintain contact to the artery wall: this inadequate implantation called malapposition can lead to adverse clinical events and heart attacks.
The STENTYS Self-Apposing Stent is engineered to solve the dilemma of artery diameter discrepancy. Its flexible, self expanding design takes the shape of the patient’s unique vessel anatomy and perfectly apposes to the irregular contours of a blood vessel.
The CE Mark certificate of the Self-Apposing Stent was updated on the basis of additional clinical evaluation and now includes specific patient subsets such as those with tapered, aneurysmatic, ectatic (dilated) or very large vessels or those with bypass grafts. Contraindications such as chronic total occlusions and left main bifurcations have also been lifted. These changes allow STENTYS to commercialize its Self-Apposing Stent in new market segments that represent approximately 10% of all percutaneous coronary interventions in Europe.
“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,” said Gonzague Issenmann, CEO and co-founder of STENTYS. “We are excited that the new product label should allow us to develop these new high-value market segments beyond our traditional heart attack market.”
Source: STENTYS
STENTYS Self-Apposing Stent Approved in Europe for Additional Coronary Indications
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