The CorCap CSD is the first medical device specifically designed to address the problem of enlargement of the heart, a major contributing factor to heart failure progression. Results from the Acorn Clinical Trial of the CorCap CSD were presented by principal investigator, Dr. Douglas Mann of the Michael E. DeBakey VA Medical Center and Baylor College of Medicine.

The CorCap Cardiac Support Device helps an enlarged heart recover a more normal size and shape. As a result, patients feel better and require fewer costly medical interventions to treat their heart failure, commented Dr. Mann. These clinical trial results should bring hope to thousands of heart failure patients whose lives have been severely affected by this debilitating disease, says Acorn.

Mesh Wrap

CorCap CSD therapy could improve outcomes for the many patients who are not helped by drugs alone, the company says. The CorCap CSD is a proprietary mesh wrap that is implanted around the heart to provide gentle support, relieving the stress that is caused by an unhealthy increase in heart size.

Clinical trial data revealed that in comparison with a control group, those patients who were treated with the CorCap CSD:

• Demonstrated sustained improvements in heart size and shape.

• Showed significant improvements in quality of life using standardized evaluation methods.

• Were 50 percent less likely to require additional cardiac procedures for worsening heart failure, such as transplants and implants of ventricular assist or electrical stimulation devices.

"The presentation of promising results from our Acorn Clinical Trial marks the beginning of a new era in heart failure therapy," Acorn Cardiovascular President and Chief Executive Officer Rich Lunsford stated. "In the past, patients with enlarged hearts had very few treatment options. The positive trial results bring us one step closer to making a breakthrough therapy widely available to heart failure patients."

The Acorn Clinical Trial is a scientific evaluation comparing treatment with the CorCap CSD versus traditional therapies. The trial involved 300 patients at 29 centers across North America, making it the most extensive controlled evaluation of a surgical treatment for heart failure ever conducted.

Patients participating in the Acorn Clinical Trial had symptomatic heart failure with enlargement of the heart and were being treated with optimal drug therapy, including beta-blockers and ACE inhibitors.

Heart Failure Epidemic

Heart failure is a progressive and debilitating disease that stems from heart muscle damage, often caused by heart attacks, valvular disorders or uncontrolled high blood pressure. As the heart attempts to supply the body with adequate blood, the stress on the heart builds in a degenerative cycle of muscle damage, often leading to an unhealthy dilation of the heart.

An oversized heart cannot efficiently pump blood to meet the body s needs, leading patients to become fatigued and short of breath, even with activities such as climbing stairs or walking short distances.

Up to 50 percent of patients with advanced heart failure die within five years of diagnosis. Heart failure affects more than five million people in the United States and 25 million people worldwide. The alarming growth rate -- an estimated 550,000 new cases are diagnosed each year in the United States alone -- led the U.S. National Heart, Lung and Blood Institute to categorize heart failure as an epidemic.