Orqis Medical receives FDA conditional approval for pivotal trial of cardiac recovery system


Cancion® CRS™ Therapy studied for treatment of acutely decompensated heart failure

Lake Forest, CALIF. (July 19, 2004) – Orqis Medical Corp. today announced that it has received FDA conditional approval to conduct a multi-site, randomized clinical trial of its Cancion® CRSTM therapy to investigate its effectiveness in treating patients with acutely decompensated heart failure. The Cancion CRS therapy is a percutaneous cardiac recovery system designed to create a "rest-to-recovery" environment for congestive heart failure (CHF) patients.

The principal investigator for the Multicenter trial of the Orqis Medical CRS for the ENhanced Treatment of CHF, Unresponsive to Medical Therapy (MOMENTUM), will be Barry Greenberg, M.D., Director of the Heart Failure/Cardiac Transplantation Program at the University of California, San Diego Medical Center.

"The Cancion CRS will fill a significant gap in available therapies for the acute heart failure syndrome," said Dr. Greenberg. "Its performance will be assessed in the most critical patients with the goal of providing physicians a new option for getting their heart failure patients feeling better and out of the hospital."

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.

"We are pleased at the tremendous progress we've made and look forward to beginning this next phase in the development of the Cancion CRS Therapy," said Ken Charhut, president and CEO of Orqis Medical. "The MOMENTUM trial brings us closer to offering promising benefits to patients with congestive heart failure."

"The Orqis Cancion CRS draws upon a novel mechanism of action," said Marvin A. Konstam, M.D., Medical Director of Orqis Medical and Chief of Cardiology at Tufts-New England Medical Center in Boston. "Use of the device unloads and rests the heart, while improving kidney function. The MOMENTUM Trial is designed to demonstrate the sustained clinical benefits that result."

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 designed to reverse the consequences of abnormal aortic flow, inducing vasodilatation and improving renal blood flow. Research data shows hemodynamic improvement, reduced ventricular and atrial volumes and improved renal function. Early data also indicates that the CRS therapy may have a sustained effect after removal, offering hope for potential therapeutic recovery.

"The data collected in the Cancion CRS feasibility trial was very promising and I'm anxious to get started and see the therapy proved out in the pivotal trial," said Barbara Czerska, M.D., Medical Director of the Heart Failure Transplant Program at Henry Ford Hospital in Detroit.

The Cancion CRS therapy received the CE mark in 2001, and the FDA Investigational Device Exemption (IDE) Feasibility Trial, MOMENTUM, began in 2003. Enrollment for the pivotal trial is expected to begin in the third quarter of this year.

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.

Source: Eurekalert & others

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