Healthcare Industry News: STENT Thrombosis
News Release - May 25, 2006
Sorin Group: Six Month Clinical Results of e-Janus Registry
SORIN GROUP releases results of Janus in real world AMI patients: 6.3% MACE rate, 4.6% TLR rate and, more importantly, 0% of late STENT Thrombosis rate, which reinforces the excellent safety profile of the thromboresistant Janus platform.MILAN, Italy--(HSMN NewsFeed)--May 25, 2006--Sorin Group (MIL:SRN) (ISIN:IT0003544431):Sorin Group, Europe's largest medical technology company specialising in the treatment of cardiovascular diseases, presented last week during the annual Paris Course on Revascularization (EuroPCR), six-month clinical results from its e-Janus international "real-world" registry, providing additional clinical evidence of the strong benefits of the Janus Tacrolimus-eluting Carbostent in the high-risk subgroup of patients with Acute Myocardial Infarction.
e-Janus is a multicenter, prospective registry, designed to collect "real-world" clinical outcomes in more than 4000 patients with coronary artery disease at more than 100 centers worldwide (except US and Japan). e-Janus is based on electronic CRFs, with a 3% site monitoring and with an independent CEC (Clinical Events Committee) reviewing and adjudicating adverse events.
In the overall population who had completed the six-month follow-up, 28.4% were diabetic patients, 50.4% were patients with multivessel disease and 23% percent of patients presented with an AMI. Dr. Koolen highlighted the outstanding results achieved in the 238 AMI patients subset, with a 6.3% MACE rate at six-month follow-up, TLR rate of 4.6% and, more importantly, a late STENT Thrombosis rate of 0%, reinforcing the excellent safety profile of the thromboresistant Janus platform.
"Real practice results are increasing their importance and we are glad to see that amongst the "real-world" AMI patients - who are the most burdensome - Janus shows to be very safe and effective", commented Stefano Di Lullo President of Sorin Group's Vascular Therapy Business Unit.
About Janus stent
Sorin's first-generation drug-eluting stent system, the Janus Tacrolimus-eluting Carbostent system, represents a breakthrough in drug-eluting stents. Compared to other drug-eluting stents, JANUS has the following key benefits:
JANUS requires no polymer to carry the drug (Tacrolimus, a cytostatic drug also known as FK506, produced by Astellas), eliminating the shortcomings often associated with polymers;
JANUS utilizes a proprietary drug-release system with reservoirs on the stent's outer surface, ensuring targeted release only towards the vessel wall segment requiring treatment;
JANUS virtually eliminates the risk of thrombosis with its proven and highly bio- and haemo-compatible Carbofilm(TM) coating technology;
JANUS facilitates direct stenting, avoiding the need for predilatation, thus reducing the overall cost of the procedure.
About Sorin Group
Sorin Group (Reuters code: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. Sorin Group includes: Dideco, CarboMedics, COBE Cardiovascular, Stockert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. Sorin Group has more than 4,700 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.
For additional information, please visit our website: www.sorin.com
Source: Sorin Group
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