Orqis Receives Unconditional FDA Approval to Conduct CHF Trial

Orqis Medical, developer of the catheter-based Cancion cardiac recovery system (CRS) to treat congestive heart failure (CHF), announced FDA unconditional approval for researchers to treat up to 200 CHF patients at 40 centers participating in the company's MOMENTUM (Multicenter Trial of the Orqis Medical CRS for the Enhanced Treatment of CHF, Unresponsive to Medical Therapy) pivotal clinical trial.

The Cancion CRS is the first therapy for congestive heart failure based on continuous aortic blood flow augmentation to the descending aorta. The MOMENTUM 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. The company previously announced conditional FDA approval in January to expand the MOMENTUM clinical investigation from 8 to 40 research centers nationwide.