STENTYS Enrolls First Patient in Left Main Clinical Trial
Business Wire: July 19, 2016 – PRINCETON, NJ, U.S.A., and PARIS, France – STENTYS (Paris: STNT) (FR0010949404 — STNT), a medical technology company commercializing the world’s first and only Self-Apposing® coronary stent, today announced that it has commenced enrolling patients in the TRUNC trial, which is designed to evaluate the long-term safety and efficacy of the Xposition S stent in the treatment of unprotected left main coronary artery disease.
The first implantation was performed at Treant hospital in Emmen, the Netherlands. Dr. Rutger Anthonio and Dr. Gillian Jessurun commented, “The procedure went very smoothly. The Xposition S stent is perfectly suited for the treatment of left main lesions, because it guarantees excellent apposition in a vessel segment with substantial diameter variation. In addition, the stent allows easy access to any anatomical side branch without the need to perform kissing balloon inflation, which minimizes overall manipulation.”
Christophe Lottin, chief executive officer of STENTYS, added, “We are delighted by the start of this study, as left main interventions account for nearly 10% of PCI. We are aiming to demonstrate that the unique properties of our Self-Apposing technology make it the most optimal treatment for this complex indication.”
TRUNC is a prospective, single-arm, multi-center trial to evaluate the long-term safety and efficacy of the Xposition S stent in the treatment of unprotected left main lesions in routine clinical practice. It is scheduled to include 200 patients in approximately 20 European clinical sites. The primary endpoint is target lesion failure at 12 months. The trial’s steering committee is composed of Prof. Tamburino and Dr. Briguori (Italy) and Dr. Baumbach (U.K.).
STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex artery disease. STENTYS’s Self-Apposing® drug-eluting stents are designed to adapt to vessels with ambiguous or fluctuating diameters in order to prevent the malapposition problems associated with conventional stents. The APPOSITION clinical trials in the treatment of acute myocardial infarction showed a very low one-year mortality rate and a faster arterial healing compared to conventional stents. The company’s product portfolio also includes MiStent SES® , a coronary DES whose new drug delivery mechanism is designed to match vessel response, and is marketed through STENTYS’s commercial network in Europe, the Middle East, Asia, and Latin America.
