Sorin Group: ELA Medical, Inc. Files PMA Submission for Ovatio(TM) CRT.ELA Medical, Inc, a Sorin Group Company, Has Filed a Pre-Market Approval with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for the Smallest CRT-D Available to Patients Outside the US ARVADA, Colo. -- Ela Medical, Inc., a Sorin Group (MIL:SRN) Company and a member of the Sorin Group Cardiac Rhythm Management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. (CRM) Business Unit, today announced that it has filed a pre-market approval application (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA) seeking approval to market OVATIO[TM] CRT (1) (C RunTime) See runtime library. (2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons. , 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 Sudden Cardiac Death Definition Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest. (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 Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. 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 de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction condition. Andre-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: 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., St[?]ckert, 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. For more information: www.sorin.com |
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