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News Release 2005 - March 10
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Physicians of the Texas Heart Institute at St. Luke's Among First
to Study New Cardiac Recovery System for Severe Heart Failure

HOUSTON (March 10, 2005) Physicians at the Texas Heart Institute at St. Luke's Episcopal Hospital recently treated one of the first U.S. patients in a new clinical trial to study the ability of the Cancion® CRS™ (cardiac recovery system) to stabilize patients experiencing severe heart failure.

Cancion CRS (cardiac recovery system)

Cancion® CRS™ (cardiac recovery system) 
Illustration: Orqis Medical Corp

The cardiac recovery system is developed by Orqis Medical Corp. (Lake Forest, Calif.) and employs new discoveries in blood flow dynamics to change how congestive heart failure is treated. It is the focus of a multi-center national trial called MOMENTUM.  Interventional cardiologist Biswajit Kar, M.D., deployed the percutaneous Cancion CRS therapy in the cath lab through the femoral arteries, similar to an angioplasty procedure.

"The Cancion CRS represents a new concept in the treatment of patients with severe heart failure," said Dr. Kar.  "The patient we treated was in decompensated heart failure and not responding to medical management. With the Cancion CRS, he was stabilized over a three-day period and then weaned, discharged and returned home where he continues to do well."

Decompensation is a potentially deadly situation in which the body retains large amounts of fluids, blood flow to the body is greatly reduced and organ failure begins to set in. Effective treatment for the condition relies on timely intervention.

Advances in the knowledge of blood flow dynamics led to the development of the Cancion CRS therapy, which works by increasing blood flow in the descending aorta. Orqis' CRS creates a "rest-to-recovery" environment that allows the heart to rest while it continues to function. Because it is applied percutaneously, the device does not touch the heart and does not require synchronization with the heart and is therefore simple to apply and manage.

"This is the first heart failure therapy of its kind," said Reynolds Delgado III, M.D., medical director of mechanical support devices in heart failure at the Texas Heart Institute (THI) at St. Luke's. "It's much easier to use than other devices, and also less risky.  It's a simple, new technology that has the potential to benefit critically ill heart patients in a unique way. We are studying whether the benefits will be long lasting after resting the heart for just a few days."

Heart failure is the heart's inability to adequately pump blood through the body. About five million Americans have heart failure and well over half a million new cases are diagnosed each year.

Mark Martinez visits with Marianne Bergheim, study coordinator for the Cancion CRS pump, during a follow-up visit to the Heart and Lung Treatment and Transplant Center.

Mark Martinez visits with Marianne Bergheim, study coordinator for the Cancion® CRS™ pump, during a follow-up visit to the Heart and Lung Treatment and Transplant Center at Texas Heart Institute at St. Luke's Episcopal Hospital.

The first patient to receive the Cancion CRS therapy at Texas Heart never expected he would need it. Mark Martinez, now age 37, was first diagnosed with heart failure in 1999. He had been experiencing shortness of breath and an EKG showed an abnormal heart rate.

"I was very surprised. I had worked 15 years straight without any problems. Even though there's diabetes in my mom's family and heart problems in my dad's, I didn't think I would get it," said Mr. Martinez, who also has diabetes.

Mr. Martinez was referred to the Heart and Lung Treatment and Transplant Center at THI at St. Luke's when standard medical management could no longer bring relief from his symptoms.

"I didn't realize how sick I was when I was admitted to St. Luke's. I was experiencing fluid build-up for the first time. It got so bad that I couldn't breathe when I leaned over to tie my shoes. The pump really helped a lot. I like it so much I think they should name it after me – the Mark I!" he laughed.

The U.S. Food and Drug Administration recently approved an expansion of the Cancion CRS MOMENTUM trial from eight to 40 medical centers nationwide.

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World-renowned cardiovascular surgeon Denton A. Cooley, MD, founded the Texas Heart Institute in 1962 for the study and treatment of diseases of the heart and blood vessels. Together with the Institute's clinical partner, St. Luke's Episcopal Hospital, for the past 14 years it has been ranked among the nation's top ten heart centers in an annual survey published by U.S. News & World Report. For more information about the Institute, please visit www.texasheartinstitute.org.

St. Luke's was founded in 1954 by the Episcopal Diocese of Texas. St. Luke's is home to the world-renowned Texas Heart Institute, founded in 1962. In 2001, St. Luke's earned the Magnet designation, the highest honor in patient care. It is the first hospital in Texas and the Southwest to be so honored. For more information about the hospital, please visit www.stlukestexas.com

Contacts:

Kathy Watson
Texas Heart Institute
832-355-6569
kwatson@heart.thi.tmc.edu

Melinda Muse
St. Luke's Episcopal Hospital
832-355-3040
mmuse@sleh.com



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