Healthcare Industry News: Ela Medical
News Release - May 11, 2007
The Sorin Group Announces Release of 2007 Cardiac Rhythm Management (CRM) Product Performance Report
Sorin Group is the only CRM company that provides performance data on CRM devices implanted worldwideDENVER--(HSMN NewsFeed)--The Sorin Group today announced the release of its 2007 CRM Product Performance Report, which is the only Performance Report in the industry to provide performance data on CRM devices implanted worldwide. Available to all patients and physicians at http://www.sorin-crm.com/docs/May_2007_worldwide_PPR_doc.pdf, the new report incorporates the latest information about the company's most recent pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization devices and leads. The report provides an explanation of the statistical methods used for product performance assessment and gives information about the occurrence of CRM device malfunctions, estimated CRM product longevity, as well as the most recent updates about product advisories. All performance data presented in the report have been collected worldwide through December 31, 2006.
"At Sorin we believe that it is important to be transparent with physicians and patients and to include worldwide data, not just U.S. data, in our Product Performance Report. As a responsible, patient-focused industry player, we believe that all patients implanted with the Sorin Group products, and their physicians, should have the right to access performance data about their devices regardless of their place of origin," commented Andre-Michel Ballester, President Cardiac Rhythm Management, Sorin Group.
"The Sorin Group Quality policy is based on a philosophy of constant improvement. We continually track the field performance of our implanted devices to ensure that they perform as expected. Each observation about product performance is classified and compared with previous observations for similarities. This approach enables us to assess how our products perform with accuracy and help us enhance our manufacturing process to guarantee maximum patient safety. The Product Performance Report embodies our commitment to strive for the highest levels of performance and quality and to provide timely and reliable information on device performance to physicians and patients", said Peter Jacobson, Vice President Quality Assurance and Regulatory Affairs, Cardiac Rhythm Management, Sorin Group.
In compliance with the recommendations of the Heart Rhythm Society, the Sorin Group's Product Performance Report has been reviewed by an independent Product Performance Review Board. As a member of Advamed (U.S. Advanced Medical Technology Association), the Sorin Group works together with the other Cardiac Rhythm Management companies as well as with regulatory authorities and physicians associations to help healthcare professionals, patients and their families better assess the risks and the benefits of CRM devices.
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: Dideco, CarboMedics, Inc., COBE Cardiovascular, Inc., Stockert, Mitroflow, Ela Medical, Inc., Sorin Biomedica, Bellco and Soludia. It has more than 4,500 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers.
For more information, please visit our web site: www.sorin-crm.com or www.sorin.com.
Source: Sorin Group
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