Heart jacket offers potential innovative treatment for heart failure

September 27, 2001

DETROIT - Mark Szep, 34, of Chesterfield Township, Mich., recently underwent Henry Ford Hospital's first surgical implantation of the Acorn CorCap™ Cardiac Support Device, a potential innovative treatment for heart failure.

During the procedure, the CorCap, a mesh-like heart "jacket," was slipped around Szep's heart and stitched into place. Made from a proprietary medical fabric, the CorCap is designed to support the heart, prevent further enlargement of the muscle and enhance pumping function.

The surgery was performed by cardiothoracic surgeon Robert Brewer, M.D. Szep remains under the care of Barbara Czerska, M.D., director of Heart Failure at the Henry Ford Heart & Vascular Institute, who has been treating him for heart failure for the last three years.

"Heart failure can be caused by heart attack, viral infection, or other factors which cause the cardiac muscle to deteriorate and the muscle cells to begin to die," said Dr. Czerska. "The heart often weakens and enlarges as it works harder to pump blood throughout the body. This progressive enlargement is detrimental."

She continued: "The CorCap is based on the concept that if enlargement of the heart can be stopped, the fatal progression to overt congestive heart failure can be significantly slowed or even halted."

Nationally recognized for its heart failure program, Henry Ford is a recent addition to the CorCap randomized trial that is currently enrolling patients. To date, the device has been implanted in 19 people in the United States.

Heart failure affects nearly 23 million people worldwide and nearly 5 million people in the United States. Well over 50 percent of patients will die within five years of diagnosis. The disease is becoming more prevalent and few treatment options exist. It is one of the most expensive health care problems in developed countries; in 1998, the economic cost in the United States was almost $40 billion.

Hani (Tony) Sabbah, Ph.D., director of Henry Ford's Cardiovascular Research Laboratories, led the laboratory research and development of the CorCap device that was three years in the making. Dr. Sabbah oversaw the first implantation at the beginning of the regulated clinical safety trial in Europe.

The CorCap™Cardiac Support Device is intended to halt the progression of heart failure. Pre-clinical studies demonstrated that the CorCap prevents progressive enlargement of the heart, improves the pumping function and eliminates back-flow of blood through the mitral valve. In a pre-clinical study presented at the Scientific Session of the American College of Cardiology in March, Dr. Sabbah demonstrated that the device also helps to slow heart muscle cell death.

Acorn is sponsoring the multi-center clinical trial under an FDA-approved Investigational Device Exemption (IDE) to determine the safety and efficacy of the CorCap in stabilizing or reducing heart size and improving cardiac function in patients with heart failure. Acorn has received CE Mark Approval for the CorCap in Europe.

Patients interested in finding out if they are candidates for the CorCap randomized trial at Henry Ford Hospital should contact the Heart Failure Clinic at 313-916-2895.
Acorn Cardiovascular, Inc., a privately held company based in St. Paul, Minn., was founded in late 1996 with the goal of developing less-invasive implantable devices to bring improved quality of life to heart failure patients. More information is available at http://www.acorncv.com.

The Henry Ford Heart & Vascular Institute is a leader in comprehensive care, research and education, offering one of the nation's most successful heart failure treatment, transplant and rehabilitation programs. In 2001, it was ranked 18th in cardiology/cardiovascular surgery by U.S. News & World Report. For more information and photos of the Acorn CorCap™ Cardiac Support Device, go to http://www.henryford.com/body.cfm?id=33666&action=detail&ref=302

Henry Ford Health System

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