Healthcare Industry News:  Ela Medical 

Devices Cardiology FDA

 News Release - July 27, 2006

Sorin Group Receives FDA Approval for the Production of Carbomedics Valves in Saluggia

The Food and Drug Administration inspection of the heart valves manufacturing site in Saluggia (Vercelli, Italy) has successfully completed. The production of the Carbomedics valves has been moved from Austin (Texas, USA)

MILAN, Italy--(HSMN NewsFeed)--July 27, 2006--Sorin Group (MIL:SRN), worldwide leader in cardiac surgery solutions, received the clearance from FDA to manufacture Carbomedics mechanical heart valves in the firstclass manufacturing facility in Saluggia (Vercelli, Italy).

The inspection performed by the FDA on the Heart Valves Business ended successfully. This result represents not only an important acknowledgement of the high quality standards of the Sorin valves production processes, but also a fundamental step in the industrial integration and consolidation process of the Group.

While the production of mechanical cardiac valves has been consolidated in one firstclass manufacturing facility in Saluggia (Vercelli, Italy), the Austin facility will continue to serve as the assembly location of the finished products for the North American market.

This production shift will enable the Group to benefit from economies of scale and exploit the technological knowhow developed through the work carried out in Saluggia over several decades. Since 1977, hundreds of thousands of mechanical valves have been manufactured at Saluggia, and have been implanted in more than 70 countries without any structural malfunction.

"We are extremely proud and excited about this important result, which is the evidence of the excellent quality of our people and manufacturing processes of the Sorin Group", said Franco Vallana, President Cardiac Surgery Business Unit.

The benefits that this integration effort is expected to produce include: greater operational flexibility in managing brands and product lines, enabling the Group to respond to any shifts in market demand; major economies of scale and reduction of manufacturing costs; and greater integration between the manufacturing and R&D organizations.

Drago Cerchiari, Sorin's CEO, declared: "This production relocation will result in a strategic reinforcement of the overall Cardiac Valves area, which will benefit from the world's greatest concentration of medical technology resources and product specific knowhow."

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. The companies of Sorin Group are: Bellco, CarboMedics, COBE Cardiovascular, Dideco, Ela Medical, Mitroflow, Soludia, Sorin Biomedica and, Stockert. Sorin Group has about 4,800 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.

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Source: Sorin Group

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