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Stentys CE marks self-expanding stent

This article was originally published in Clinica

Executive Summary

Stentys has CE marked its self-expanding stent, designed to treat acute coronary syndrome (ACS), for sale in Europe. Its self-expanding nature means the stent's struts remain in contact with the blood vessel's internal surface, even during thrombus and vessel spasm relief. This helps avoid malapposition in the initial hours and days after an acute myocardial infarction (AMI) procedure. A randomised trial comparing Stentys' product with a conventional balloon-expandable stent in AMI patients is underway. The study will use extremely high-resolution optical coherence tomography imaging to validate endpoints, and will specifically assess stent apposition and adaptation to vessel growth.

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