STENTYS Announces the Publication of New Self-Apposing Stent Study in Left Main Coronary Artery

Regulatory News :

STENTYS (Paris:STNT) (FR0010949404 — STNT), a medical technology company commercializing the world's first and only Self-Apposing^® coronary stent, today announced that new data on the Self-Apposing stent in the challenging treatment of the Left Main coronary artery was published in the peer-reviewed journal Catheterization and Cardiovascular Interventions (CCI) and the authors concluded that the STENTYS DES offers a valid treatment alternative for this indication.

When treating patients with left main coronary artery disease, especially in the setting of a heart attack, the large diameter of the left main artery and the significant vessel tapering at that location represents serious challenges for conventional balloon-expandable DES that often result in important stent structural deformations. The STENTYS DES can adapt to vessels with varying diameters and ensure optimal fit to the vessel wall along the entire stented length.

The single center, retrospective, two-arm, controlled study, led between February 2012 and September 2013 by a team headed by Carlo Briguori, MD, PhD, (Clinica Mediterranea, Italy), included 75 consecutive patients with tapered distal unprotected left main coronary artery lesions treated with the STENTYS DES. A control group of 75 patients treated with second-generation balloon-expandable DES over the same period was selected from the New Tokyo Hospital (Chiba, Japan) database.

The results, assessed by intravascular ultrasound (IVUS), showed that the final minimal lumen area was larger in the STENTYS DES group (left main: 17.45±3.45 vs. 14.84±3.45 mm²; p<0.001) even though the final balloon diameter was smaller (3.62±0.49 vs. 4.51±0.51 mm; p<0.001), reducing the risk of vessel injury.

"In the very complex indication of Left Main artery disease, STENTYS DES achieved 100% procedural success rate, 9.3% MACE rate at 12 months and, most importantly, larger vessel lumen than second generation balloon-expandable DES without the need for aggressive over-dilation,” said Dr Briguori.

Gonzague Issenmann, co-founder and Chief Executive Officer of STENTYS commented: "This study shows that the Self-Apposing technology represents a compelling alternative to treat Left Main coronary artery disease and provides further clinical proof of the perfect adequacy for vessels of varying diameters.”

References: The STENTYS^® paclitaxel-eluting stent in the treatment of unprotected distal left main. Carlo Briguori MD, PhD, Gabriella Visconti MD, Michael Donahue MD, Amelia Focaccio MD, Satoru Mitomo MD, Hiroyoshi Kawamoto MD and Sunao Nakamura MD. Catheter Cardiovasc Interv. 2015 Jan 30. DOI: 10.1002/ccd.25874.

About STENTYS
STENTYS is developing and commercializing innovative solutions for the treatment of patients with complex artery disease. STENTYS’ 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’ commercial network in Europe, the Middle East, Asia and Latin America.
More information is available at www.stentys.com.

Safe Harbor Statements
This press release contains forward-looking statements about the Company’s business. Such forward looking statements are based on numerous assumptions regarding the Company’s present and future business strategies and the environment in which it will operate in the future which may not be accurate. Such forward-looking statements involve known and unknown risks which may cause the Company’s actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks associated with the development and commercialization of the Company’s products, market acceptance of the Company’s products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, uncertainties related to the U.S. FDA approval process, slower than expected rates of patient recruitment for clinical trials, the outcome of clinical trials, and other factors, including those described in the Section 4 "Risk Factors” of the Company’s 2013 Registration Document (document de référence) filed with the French Autorité des Marchés Financiers on October 29, 2014 under number D.14-1026 as such section may be updated from time to time.

STENTYS is listed on Comp. B of the NYSE Euronext Paris
ISIN: FR0010949404 – Ticker: STNT