Healthcare Industry News:  Ela Medical 

Devices Cardiology Regulatory

 News Release - April 21, 2008

Sorin Group Receives Approval to Market S5 Heart-Lung Machine in Japan and Announces Landmark Shipment of 7000th Heart-Lung Machine

TOKYO & MILAN, Italy--(HSMN NewsFeed)--The Sorin Group (MIL:SRN), the largest European cardiovascular company and world leader in medical technologies for cardiac surgery, announces that it received the Japanese Pharmaceutical and Medical Devices Agency’s (PMDA) approval to market its Stöckert S5 Heart-Lung Machine in Japan.

Every year, over one million patients in the world undergo life-saving open-heart procedures supported by heart-lung machines.

With more than 30 years of experience in the cardiopulmonary business field, the Sorin Group is the undisputed leader in the manufacturing and marketing of heart-lung machines, with a share of over 60% of the installed base of machines. It works closely together with perfusionists across the globe in order to ensure that the most advanced features and technologies are adopted and better patient outcome is achieved. As a testament to this, the 7,000th perfusion system - a S5 heart-lung machine - was recently shipped to Brisbane, Australia.

Launched in Europe, U.S. and rest of the world between end 2005 and 2006, the Stöckert S5 is the fifth-generation of heart-lung machines and the successor to Sorin Group's SIII perfusion system. The S5 state-of-the-art technology sets new standards for safety, functionality and quality and will help hospitals achieve better patient outcome. For example, the smaller footprint of the S5 allows closer positioning of the unit to the patient, effectively reducing line lengths and the possibility of hemodilution. In addition, acoustically differentiated alarms and information displayed on the high-resolution touch screens clearly describe the status of all monitoring functions of the extracorporeal circuit. Furthermore, the S5 has no boot-up time: this means that the pumps are operable three seconds after turning the system on, which is extremely important in emergency situations. In fact, the S5 does not use PC-based technology to control the system: all modules are directly programmed to perform a perfusion specific function and are completely interchangeable.

“With the launch of the new S5 in Japan, I am confident the Sorin Group will gain market leadership in heart-lung machines in this key country and further consolidate its leading worldwide market share”, said Michel Darnaud, President, Cardiopulmonary Business Unit and Intercontinental, Sorin Group.

About the heart-lung machine

A heart-lung machine is a sophisticated piece of medical equipment that helps keeping a patient alive when undergoing an open-heart cardiac surgery procedure: it provides blood circulation and oxygenation to organs and brain while the patient’s heart and lungs are temporarily stopped.

About the Sorin Group

The Sorin Group (Bloomberg: SRN.IM; Reuters: 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 Sorin Group includes these brands: Dideco, CarboMedics, COBE Cardiovascular, Stöckert, Mitroflow, Ela Medical, Sorin Biomedica, Bellco and Bellco-Soludia. At the Sorin Group 4,500 employees work to serve over 5,000 public and private treatment centers in more than 80 countries throughout the world.

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Source: Sorin Group

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