May 29, 2007 — Orqis Medical Corp., a clinical-stage company developing devices for the treatment of congestive heart failure (CHF), has announced that the 150th patient has been enrolled in the MOMENTUM Pivotal Trial. With 200 patients needed for study completion, the trial is now 75 percent enrolled.
The MOMENTUM Pivotal Trial is studying the use of the company's percutaneous Cancion System in heart failure patients. The novel Cancion System is designed to treat patients hospitalized with decompensated heart failure who inadequately respond to medical therapy.
The device works by continuously augmenting blood flow in the descending aorta throughout the cardiac cycle. The MOMENTUM Pivotal Trial is assessing the safety and effectiveness of the Cancion System across 40 U.S. clinical sites in preparation for a U.S. Food and Drug Administration PMA filing. The device is CE marked and available in select overseas markets.
"Reaching the MOMENTUM Pivotal Trial's 75 percent enrollment milestone with nearly 50 patients enrolled this year to-date is a clear reflection of the enthusiasm for this novel approach to treat decompensated heart failure," said Barry Greenberg, M.D., the principal investigator for the trial and the director of the Advanced Heart Failure Treatment Program at the University of California-San Diego School of Medicine.
Orqis Medical's Cancion System feasibility study, published November, 2005 in the journal, "Circulation," found that treatment with the Cancion System led to improved vascular, renal and cardiac measures. The MOMENTUM Pivotal Trial was designed to help confirm those benefits.
For more information visit www.orqis.com and www.momentumtrial.com.