Stentys, developer of the world’s first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), has received approval to expand the CE Mark indications of its product. Now included in the indications are a variety of conditions and anatomical variations, and some contraindications have been lifted.
The CE Mark certificate of the Self-Apposing Stent has been widened to 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. Stentys says these changes allow it to commercialize the device in new market segments, representing approximately 10% of all percutaneous coronary interventions in Europe.
We’ve covered the Stentys system before, most recently in January when a new study confirmed that its design prevented malapposition, one of the occupational hazards of traditional stents. The company’s Self-Apposing Stent is engineered to solve the dilemma of artery diameter discrepancy, its flexible, self expanding design taking the shape of the patient’s unique vessel anatomy and perfectly apposes to the irregular contours of a blood vessel.
“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.”