CE Mark Issued for the CorRestore System, Announces Somanetics Corporation.Business Editors/Health/Medical Writers TROY, Mich.--(BUSINESS WIRE)--April 28, 2003 Somanetics Corporation (Nasdaq:SMTS SMTS Space and Missile Tracking System SMTS Senior Member of Technical Staff SMTS Saskatchewan Mathematics Teachers' Society (Canada) SMTS So Much to Say (Dave Matthews Band song) ) announced today that it has received CE Mark certification for the CorRestore(TM) System. CE Mark certification designates that the CorRestore System meets the safety and quality standards set forth by the European Community, and allows Somanetics to market it in European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community countries. "We are pleased to achieve this milestone," said Bruce Barrett, president and chief executive officer of Somanetics. "However, its achievement does not alter our financial projections for fiscal 2003." The CorRestore System includes the CorRestore Patch, an implant designed for use in cardiac repair and reconstruction, including Surgical Ventricular Restoration, SVR Noun 1. SVR - Russia's intelligence service responsible for foreign operations, intelligence-gathering and analysis, and the exchange of intelligence information; collaborates with other countries to oppose proliferation of weapons of mass destruction, terrorism and , a surgical treatment for patients with certain types of severe congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. . In patients with certain types of 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 congestive heart failure, the left ventricle left ventricle n. The chamber on the left side of the heart that receives the arterial blood from the left atrium and contracts to force it into the aorta. dilates and becomes severely weakened. During SVR with the CorRestore System, the surgeon implants the CorRestore Patch to restore the enlarged, poorly-functioning left ventricle to more normal size and function. SVR with the CorRestore System restores the geometry of the heart, directly addressing the underlying cause of the heart disease, compared to other treatments such as drugs and cardiac assist devices which help to reduce the symptoms of congestive heart failure. The CorRestore Patch component is made from bovine pericardium pericardium: see heart. (cow heart-sac tissue) and is designed to standardize the implantation during cardiac repair. Soft and flexible, the CorRestore Patch has a rigid inner ring that is surrounded by a contoured outer rim to provide a seal against leaks at the perimeter. About Somanetics Somanetics manufactures and markets the INVOS(R) Cerebral Oximeter oximeter /ox·im·e·ter/ (ok-sim´e-ter) a photoelectric device for determining the oxygen saturation of the blood. ox·im·e·ter n. Pulse oximeter. , the only noninvasive and continuous monitor of changes in regional brain blood oxygen saturation that is commercially available in the U.S. Use of the INVOS Cerebral Oximeter helps medical professionals, such as surgeons and anesthesiologists, identify regional brain blood oxygen imbalances and take corrective action. Such action can prevent or reduce neurological injuries related to adverse events during surgery or in the critical care unit and reduce the associated cost of care. Somanetics also markets the CorRestore System, a cardiac implant for use in cardiac repair and reconstruction, including a procedure called Surgical Ventricular Restoration, SVR, a treatment for patients with certain types of severe congestive heart failure. Somanetics' web site address is www.somanetics.com. |
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