Healthcare Industry News:  CarboMedics 

Devices Interventional Cardiology

 News Release - February 20, 2006

Sorin Group: Janus Tacrolimus Eluting Carbostent Demonstrates Excellent Safety Profile and Clinical Efficacy in "Real-World" Patients, Particularly in Those With Acute Myocardial Infarction

First Six-Month Clinical Findings From e-Janus Registry Presented at JIM Congress in Rome

ROME, February 20 (HSMN NewsFeed) -- Sorin Group, Europe's largest medical technology company specialising in the treatment of cardiovascular diseases, presented last week the first six-month clinical results from its e-Janus international "real-world" registry.

The data presented at the JIM congress in Rome on Friday 17th February 2006, confirm that the Janus Tacrolimus eluting Carbostent provides excellent safety profile and clinical efficacy for the treatment of "real-world" patients, including high-risk AMI (Acute Myocardial Infarction) patient population.

While still recruiting, the e-Janus registry has currently enrolled over 2500 patients at more than 80 centres worldwide (except US and Japan). Six-month clinical follow-up on 587 patients were presented by Dr. J. Koolen (Eindhoven, The Netherlands), the Principal Investigator (PI) of the study.

In the overall population analysed (of 587 patients), Dr. Koolen reported an excellent 4.3% Major Adverse Cardiac Events (MACE) rate and a 3.1% Target Lesion Revascularisation (TLR). MACE includes death, myocardial infarction (MI; Q-wave and non-Q-wave) and target lesion revascularisation.

Furthermore, out of the 587 patients who had completed the six-month follow-up, 31% were diabetic patients, 50.4% were patients with multivessel disease and 23% per cent of patients presented with an acute myocardial infarction. The latter are considered one of the highest-risk patient subset to treat for the cardiovascular disease since they show a significant risk of further cardiac disease complications.

Dr. Koolen highlighted the outstanding results achieved in the AMI patient subset with a 3.0% Major Adverse Cardiac Events (MACE) rate at six-month follow-up. In these 133 AMI patients, the TLR rate was 2.2% and, more importantly, the late stent thrombosis rate for this high risk subgroup was 0%, which demonstrates the excellent safety profile on the thromboresistant Janus platform.

"The current e-Janus data at six months provide impressive results with the Janus stent system in treating complex "real-world" patients, especially those patients with an acute myocardial infarction." said Dr. Koolen.

Given the highly complex patients population, the results from e-Janus support the excellent safety profile and clinical efficacy of the Janus Tacrolimus eluting Carbostent in the treatment of "real-world" population.

e-Janus is a multicentre, prospective registry, designed to collect "real-world" clinical outcomes in more than 2500 patients with coronary artery disease at more than 100 centres 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.

"We are very encouraged with the initial interim results of the e-Janus study, which provide further clinical evidence of the benefits of the Janus stent across broad patient groups." said Stefano Di Lullo, Senior Vice President Vascular Therapy.

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 whatsoever to carry the drug (Tacrolimus, a cytostatic drug also known as FK506, produced by Astellas), eliminating the shortcomings often associated with polymers;

- Janus utilises 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.

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 centres.

Source: Sorin Group

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