Sorin Group: Ela Medical, Inc. files PMA submission for Ovatio™ CRT
ELA Medical, Inc, a Sorin Group company, has filed a pre-market approval with the FDA for the smallest CRT-D available to patients outside the US.
Arvada, Colorado - December 7, 2006 - Ela Medical, Inc., a Sorin Group Company and a member of the Sorin Group Cardiac Rhythm Management (CRM) Business Unit, today announced that it has filed a pre-market approval application (PMA) with the United States Food and Drug Administration (FDA) seeking approval to market OVATIO™ CRT, its latest cardiac resynchronization therapy defibrillator (CRT-D).
OVATIO CRT is currently the smallest CRT-D available to patients outside the U.S. Its reduced size and unique features are aimed at improving patient comfort.
Cardiac resynchronization therapy defibrillators are indicated in heart failure patients who might be at risk for Sudden Cardiac Death (SCD). CRT-D devices are capable of resynchronizing the contractions of the ventricles (the heart's lower chambers) by delivering low-energy impulses to the heart as well as providing patients with defibrillation support when abnormally fast, life-threatening heart rhythms occur.
With 550,000 new cases diagnosed annually in the United States, heart failure is the most costly cardiovascular disease. Approximately $40 billion are dedicated annually to the treatment of this debilitating condition.
André-Michel Ballester, President of Sorin Group Cardiac Rhythm Management (CRM) Business Unit commented: "Sorin Group is pleased to file this application with the FDA for what would be the first CRT-D device that the company will market in the U.S. We look forward to working with the Agency through this review process."
Sorin Group CRM Business Unit (www.sorin-crm.com) designs and manufactures implantable pacemakers and ICDs, leads and Holter equipment and markets them worldwide.
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, Inc., COBE Cardiovascular, Inc., Stöckert, Mitroflow, ELA Medical, Inc., Sorin Biomedica, Bellco and Soludia. Sorin Group 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.
Director, Global Communications, CRM Business Unit
Marco Chiadò Piat
VP Corporate Development, Sorin Group
Director, Investor Relations, Sorin Group
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