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Sorin Group announces the start of enrolment in the e-JAMI registry and presents the master trial |
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26 May 2006 |
MILAN, Italy | May 25, 2006 | Sorin Group announced the start of enrolment of the e-JAMI registry, designed to assess the clinical performance of Janus Flex Carbostent in the treatment of AMI patients in routine clinical practice. The enrolment started in May 2006 and the registry will involve 500 patients worldwide (except US and Japan).
Additional clinical evidence of the combined efficacy of highly biocompatible and thromboresistant Carbofilm coating together with the "smart" drug Tacrolimus (a proven cytostatic drug, which selectively inhibits smooth muscle cells proliferation and migration, while permitting enhanced re-endothelialization of the stent) will be provided by the European clinical trial MASTER (Multicenter randomized clinical trial to evaluate JAnuS Flex Tacrolimus Eluting CaRbostent as compared to Taxus Paclitaxel eluting stent in AMI patients). TM
The MASTER trial will assess the effectiveness of Janus Flex Carbostent compared to Taxus stent in the treatment of Acute Myocardial Infarction patients. The principal investigators of the trial are Dr. Colombo (Milan) as PI and Dr. Schoefer (Germany) and Dr. Garcia (Madrid) as co-PIs. Patients enrolment will start in the next few months and will involve more than 800 from more than 25 centers across Europe.
"Late stent thrombosis is a catastrophic event for patients. Cardiologists are faced with a real dilemma between achieving the proper balance between safety and efficacy in the treatment of their patients," indicated Dr. Colombo.
"MASTER will be an important trial as it will try to address the relative safety and efficacy profile of two very different drug eluting stents (with and without polymer) in patients with a relatively high risk of thrombosis. We are honoured to be associated with such a distinguished group of principal investigators," said 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:
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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;
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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;
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JANUS virtually eliminates the risk of thrombosis with its proven and highly bio- and haemo-compatible CarbofilmTM coating technology;
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JANUS facilitates direct stenting, avoiding the need for predilatation, thus reducing the overall cost of the procedure.
About Sorin Group
The 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. The companies of the Sorin Group are: Dideco, CarboMedics, COBE Cardiovascular, Stöckert, Mitroflow, ELA Medical, Sorin Biomedica, Bellco and Soludia. The 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.
SOURCE: Sorin Group |
