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Contact:
Joe Muehlenkamp
Phone: 314.977.8015
muehlenk@slu.edu
News Release

June 14, 2002

SLU Performs First-Ever Implantation of a "Heart Jacket" in Missouri

Fewer Than 100 in U.S. Have Received the Investigational Device

ST. LOUIS -- The concept is simple: to halt deterioration of the heart muscle, wrap it in a mesh-like net to prevent further enlargement in patients with heart failure. It's like a jacket for the heart.

"This is an incredibly novel approach," says Paul Hauptman, M.D., a SLUCare cardiologist and associate professor at Saint Louis University School of Medicine. "It's a potentially revolutionary approach."

Heart failure is a condition in which the heart can't circulate enough blood to meet the needs of the body. Patients who have the problem typically have enlarged hearts that continue to get larger and weaker as the condition progresses.

The CorCap Cardiact Support Device is an investigational, mesh-like heart "jacket" that is slipped around the heart during chest surgery and stitched in place to prevent any further enlargement. It is made from a custom knitted polyester fabric similar to material found in other devices permanently implanted in the body. It is intended to be an adjunctive therapy for patients with moderate to severe heart failure.

Preliminary testing has shown the CorCap is strong enough to prevent the heart from becoming larger, stretching just enough so that it doesn't interfere with the heart's normal filling and emptying. Saint Louis University School of Medicine is one of 20 sites nationwide selected to test this heart jacket, which is intended to halt the progression of heart failure, reduce heart size and improve cardiac function. Hauptman is leading the school's clinical trial in this area.

"Most of the people in the study are really sick and failing conventional medical management," Hauptman said. "The failing heart is like a globe - it's round. That's not the normal shape of a heart. This device seems to allow the resumption of a more normal shape." Acorn Cardiovascular of St. Paul, Minn., is sponsoring the multi-center clinical trial to determine the safety and efficacy of the CorCap in stabilizing or reducing heart size and improving cardiac function in patients with heart failure.

This clinical trial has four arms. Patients are first divided into two groups, depending on whether they need to have a mitral valve replacement. Patients in both these arms then are randomly divided again -- receiving either standard treatment (which will include a mitral valve replacement, if needed), or standard treatment plus the Acorn device.

Progress has been made in the last two decades in understanding and treating heart failure, especially in the areas of symptom relief and prevention of disease progression. But even with these accomplishments, multiple studies indicate that current medical treatments are limited in how far they go in preventing the progression of heart failure. The CorCap device could be a simple new strategy for treating moderate heart failure.

Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level. Saint Louis University performed the first heart transplant in the Midwest in 1972.

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Note to the media: To interview Dr. Hauptman or a patient in this clinical trial, please call Joe Muehlenkamp at 314-977-8015.
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