Healthcare Industry News:  CarboMedics 

Devices Interventional Cardiology Regulatory

 News Release - February 20, 2006

Sorin Group: Launch of Second Generation Drug Eluting Stent, Janus Flex With Best in Class Deliverability

New Delivery System of Janus Drug Eluting Stent Offers Improved Deliverability and Conformability

MILAN, Italy, February 20 (HSMN NewsFeed) -- Sorin Group, Europe's largest medical technology company specialising in the treatment of cardiovascular diseases, announced at the JIM congress that Janus Flex, its improved new generation drug eluting stent, is available in Europe. The authorisation for sale is valid for all of the countries in the European Union, where Janus Flex has been fully released.

The Janus Flex Tacrolimus eluting Carbostent stent system combines a new best in class delivery system with the unique Janus platform. Janus Flex delivers the same excellent safety profile and clinical efficacy demonstrated by the clinical performance of Janus. The new platform has been designed to offer improved deliverability and conformability in challenging anatomy, as well as providing superior flexibility.

The Janus Flex stent features the Janus stent design, a unique polymer free platform with revolutionary drug reservoir design allowing the drug to be delivered precisely to the vessel wall and a new delivery system. This new delivery system has been designed to offer improved deliverability and conformability in challenging anatomy that will benefit physicians to treat more complex lesions. Janus Flex also features an enhanced catheter tip, providing the lowest lesion entry profile available for better crossability. Pre-launch testings performed across Europe have already demonstrated its superior deliverability versus other DES currently available.

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 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.

"We are very pleased to release our second-generation drug eluting stent platform one year after the launch of the Janus Carbostent(TM). Janus Flex best in class delivery system enables physicians to reach more challenging lesions hence affording more patients with the opportunity to benefit from this innovative technology" said Stefano Di Lullo , Senior Vice President Vascular Therapy.

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.

Source: Sorin Group

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