Devices Cardiology

 News Release - September 18, 2006

Sorin Group Announces the Preliminary Results of a Multicentric Clinical Trial on Freedom Solo(TM)

The Innovative Biological Valve is Rapidly Adopted Thanks to Excellent Haemodynamic Performance, High Biocompatibility and an Easy Implant Procedure

BERLIN--(HSMN NewsFeed)--Sept. 18, 2006--During the 5th EACTS/ESTS joint Meeting, held on September 10-13 in Stockholm Sorin Group (MIL:SRN), Europe's largest medical technology company specialized in the treatment of cardiovascular diseases and leader in Cardiac Surgery, organised its second Investigator Meeting on "Solo Valve Trial", the European Multicentric Clinical study on Freedom Solo(TM) aortic bioprosthesis.

Preliminary ad interim analysis data have confirmed the excellent performances of this product in terms of haemodynamics, recovery of left ventricle systolic function, low early and late complication associated with friendly implant technique. These unique clinical features of Freedom Solo(TM) have been positively commented by different investigators and users in occasion of the Congress.

"Freedom Solo(TM) represented an innovation in the heart valve prosthesis arena, due to its unique characteristics of being a totally biological valve, virtually identical to the native valve, which can be easily and quickly implanted with a single suture line, giving superior results in terms of haemodynamics. Since its first launch in the market in late 2004, we have implanted almost 150 units at our institution with excellent results", said Dr. Beholz (Charite Hospital, Berlin, Germany).

"Our patients need three new aortic leaflets only to replace their native diseased leaflets. In clinical practice Freedom Solo(TM) allows most of the patients to avoid conventional prosthesis with polyester materials. This results in better haemodynamic performances and an improved patient well-being", said Dr. Repossini (Istituto Clinico Humanitas-Gavazzeni, Bergamo, Italy), the first worldwide implanter of Freedom Solo in 2004.

This aortic valve has no rigid support that other biological valves have, so called stented valves, in order to secure them to the appropriate position. Such design allow Freedom Solo(TM) to have a better haemodynamic performance without making the implant procedure more complex, since a single suture line only is required.

Freedom Solo(TM) is considered an easy to implant valve, with very high haemodynamic characteristics: "I was not a believer in stentless valves: I did not understand the need of a difficult and long-term implant technique in order to reach only slightly better haemodynamic results than with stented models. I am now implanting Freedom Solo(TM) because, with this valve which is totally biological and suitable to be implanted in a supra-annular position, I can obtain superior haemodynamic performances with a fast and simple implant technique, thus reaching the most benefit for my patients", said Prof Kemkes, (Bogenhousen Hospital, Munich, Germany).

Thanks to its recent implant of Freedom Solo(TM), the Zwolle hospital centre in The Netherlands is the 100th user centre of Freedom Solo in Europe.

This device represents a real break-through in the growing segment of biological heart valve prostheses, confirming Sorin Group's strong commitment to product innovation and new therapies. "Freedom Solo(TM) is the result of more than 25 years of Sorin Group in house expertise in the harvesting and treatment of biological tissues and manufacturing of high performance bioprostheses", said Franco Vallana, President of the Cardiac Surgery Business Unit.

About Freedom Solo aortic bioprosthesis

• Unique totally biological pericardial valve
• Innovative design which allow a fast and easy single suture implant technique
• 100% tissue to annulus ratio thanks to its supra-annular positioning
• Ready to implant thanks to the exclusive detoxification treatment which eliminates the need for rinsing

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, Stockert, Mitroflow, Ela Medical, Sorin Biomedica, Bellco and Soludia. The Sorin Group has more than 4,600 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.

www.sorin.com

Source: Sorin Group

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