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South San Francisco, CA January 10, 2005 Orqis Medical Corp. today announced that the U.S. Food and Drug Administration has approved an expansion of the Cancion® CRSTM clinical trial from eight to 40 medical centers nationwide, accelerating the trial's recruitment and enrollment efforts. The Cancion CRS therapy is a percutaneous cardiac recovery system being studied for its ability to create a "rest-to-recovery" environment for congestive heart failure (CHF) patients. Enrollment in the Multicenter trial of the Orqis Medical CRS for the ENhanced Treatment of CHF, Unresponsive to Medical Therapy (MOMENTUM) trial began in September of this year. "We've worked with the FDA to develop an effective protocol for the MOMENTUM trial and are gratified that we can now ramp up to a full complement of sites," said Marvin A. Konstam, M.D., Medical Director of Orqis Medical and Chief of Cardiology at Tufts-New England Medical Center in Boston. "This puts us yet another step closer to our goal of documenting the value that the Cancion therapy can bring to patients with heart failure." Heart failure is the deterioration of the heart's ability to pump blood throughout the body and adequately perfuse the major organs. According to the AHA, some five million Americans have heart failure and an additional 550,000 are diagnosed annually. The single most expensive diagnosis in the U.S. health care system, acutely decompensated heart failure, represents 1 million primary and 2.5 million secondary hospital admissions annually. About The Cancion CRS Therapy A breakthrough discovery in hemodynamics -- the simple supplementation of blood flow specifically in the descending aorta -- led to the development of the Cancion CRS therapy, which centers on the novel use of a blood pump and proprietary peripheral access to the circulatory system. The Cancion CRS increases blood flow in the descending aorta without taking over the function of the heart, without requiring synchronization of the heart, and without ever touching the heart. It is being studied for its ability to reverse the onsequences of abnormal aortic flow, induce vasodilatation and improve renal blood flow. Studies will also focus on hemodynamic improvement, reduced ventricular and atrial volumes and improved renal function, as well as whether the CRS therapy may have a sustained effect after removal, offering hope for potential therapeutic recovery. The Cancion CRS therapy received the CE mark in 2001, and the FDA Investigational Device Exemption (IDE) Feasibility Trial, MOMENTUM, began in 2003. About Orqis Medical [Orqis" Medical] Corporation is a privately held, clinical-stage medical device company that is applying its discovery of a new hemodynamic principle to change the way congestive heart failure is treated. Founded in 1997, Orqis Medical is headquartered in Lake Forest, Calif. For more information visit www.orqis.com. |
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