PARIS – may 24, 2017 7: 30 am CEST – STENTYS (FR0010949404 STNT eligible PEA PME), a medical technology firm that markets the stent self-apposing coronary Exhibits S, announces today that it has presented the results of follow-up final of two clinical studies on its stents at the congress of EuroPCR held in Paris last week. The Pr. Robert-Jan van Geuns (Erasmus Medical Center, Rotterdam, the Netherlands), presented the clinical results at 3-year follow-up study APPOSITION IV during a session of oral entitled Self-expandable sirolimus-eluting stent in STEMI: long-term OCT follow-up results from the APPOSITION IV study
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APPOSITION IV was a prospective clinical study, randomized, multicenter, designed to evaluate the stent STENTYS Sirolimus-eluting (STENTYS SES) compared to the stent Medtronic Resolute® in the treatment of myocardial infarction with extra-offset of the ST segment (” ST+ “). Presented in 2014, the results at 9 months showed a better efficiency and a healing blood quicker with STENTYS SES compared to stents and conventional balloon. These results were contributed to the CE marking of the STENTYS ITS year-end 2014.
An extension of the study APPOSITION IV with follow-up angiographic and intravascular imaging has been carried out to assess the positive effects of STENTYS ITS patients “ST+” in the long term. The overall results of the follow-up at 3 years showed that the vessels treated remain patents with a diameter of light-stable means, and a loss of light late very low (average of 0.24 mm). They also demonstrate the excellent apposition of the stent over a long period. The expansion of the stent remains limited, without the creation of an aneurysm.
Dr. Christoph K. Naber (Contilia Heart and Vascular Center, Essen, Germany) presented the clinical results at 4 years of follow-up of the study OPEN II during a session of oral entitled Self-expanding DES in coronary bifurcation lesions at 48 months follow-up: long-term results from the OPEN II trial
OPEN II was the largest non-randomized study evaluating the first-generation stent self-apposing drug eluting (paclitaxel) in lesions of bifurcations coronary in over 200 patients (excluding the bifurcations of the common trunk left).
The results at 4 years of follow-up shows limited rate of adverse events major cardiac (MACE), with a low increase. These results confirm that the stent STENTYS is a real alternative to stents assets conventional balloon in the so-called provisional (recommended approach currently).
Christophe Lottin, ceo of STENTYS, comments : “We are delighted with the interest aroused by the final results of our studies APPOSITION IV and OPEN II to the scientific community met in Paris on the occasion of EuroPCR. The data presented in this occasion confirms the benefits of the technology self-apposante to treat multiple clinical indications in specific duration. These findings support our growth strategy articulated around the stent Exhibits S and its target indications. We are confident that our stent Exhibits will be used in an increasing number of indications and that its technical characteristics with no equivalent in make a reference. “Moreover, the results of the study, DESSOLVE III have been published directly by MiCell at the occasion of EuroPCR and can be viewed on this link.
http://www.micell.com/micell-technologies-announces-mistent-achieved-primary-endpoint-comers-randomized-clinical-trial-versus-xience-mistent-data-subject-three-europcr-2017-presentations
General assembly
The mixed general meeting of STENTYS on 2nd convocation will be held on June 22, 2017 16: 21 place de la Madeleine, 75008 Paris. The preparatory documents for this meeting, including the form of voting by correspondence are available on the website of the company www.stentys.com, under the heading ” Investors / Documentation / general Meetings.
About STENTYS
STENTYS develops and markets innovative solutions for the treatment of patients with arterial disease complex. Stents self-apposing assets of STENTYS are designed to adapt to vessels of diameter ambiguous or variable, in order to avoid the problems of mal-apposition related to the stents of conventional design. The programme of clinical studies APPOSITION in the treatment of myocardial infarction showed a very low mortality rate and a healing blood quicker than with the stents of conventional design. The range STENTYS also includes MiStent SES® coronary stent assets of the new mechanism of drug release is adapted to the reaction vessel, and is marketed by the sales network of STENTYS in Europe, the Middle East, Asia, and Latin America. More information on www.stentys.com.
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