Orqis® Medical receives unconditional FDA approval for pivotal trial of percutaneous CHF therapy
Lake Forest, Calif. – April 26, 2005 – Orqis Medical Corporation, developer of the novel and proprietary catheter-based Cancion® cardiac recovery system (CRS
TM) to treat congestive heart failure (CHF), today announced U.S. Food and Drug Administration (FDA) unconditional approval for researchers to treat up to 200 CHF patients at 40 centers participating in the company's MOMENTUM pivotal clinical trial.
The Company previously announced conditional FDA approval in January to expand the MOMENTUM clinical investigation from 8 to 40 research centers nationwide.
"The Cancion CRS offers the promise of an exciting new percutaneous therapeutic modality to treat patients suffering from CHF," said Ken Charhut, Orqis Medical's president and CEO. "Unconditional FDA approval to advance the MOMENTUM clinical investigation will allow us to discover its therapeutic potential."
The Cancion CRS is the first therapy for congestive heart failure based on continuous aortic blood flow augmentation to the descending aorta. The MOMENTUM (Multicenter Trial of the Orqis Medical CRS for the Enhanced Treatment of CHF, Unresponsive to Medical Therapy) trial will determine efficacy of the Cancion CRS Therapy to treat patients with acute decompensation resulting from CHF.
Traditional therapies to treat acute CHF include drugs that pull off fluid (diuretics) or cause the heart to pump more strongly (inotropes). In contrast, the Cancion CRS is designed to create an environment that allows the heart to rest while it recovers from an acute decompensation event.
Congestive heart failure is a chronic disease that affects an estimated 5 million people in the U.S. with a projected cost of $27.9 billion in 2005.
Source: Eurekalert & others
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