Inova Fairfax Hospital Initiates Enrollment for Heart Failure Clinical Trial

Study to Explore Effectiveness of Implantable ‘Net’ Device

Falls Church, VA  – (May 13, 2009) – Inova Fairfax Hospital is participating in a new research study for HeartNet™, a cardiac-support device that is wrapped around the heart. The PEERLESS-HF study (Prospective Evaluation of Elastic Restraint to Lessen the Effects of Heart Failure) is a phase III clinical trial.

Delivered through the HeartNet™ Ventricular Support System, the elastic nickel-titanium mesh device is designed to reinforce the walls of the heart and slow or stop its enlargement. By augmenting the heart’s pumping chambers, or ventricles, the device has shown the potential to help the heart work more efficiently and decrease the debilitating symptoms of heart failure.

“Heart failure is an epidemic in this country with half a million new patients being diagnosed annually, with no cure in sight,” said Shashank Desai, MD, Medical Director, Heart Failure and Transplant Program at the Inova Heart and Vascular Institute (IHVI), and lead investigator for the PEERLESS study at IHVI . “Current medical therapy only delays cardiac deterioration and we remain constantly on the search for new therapies.  We’re excited about the HeartNet device because many patients continue to decline despite our best medical treatment. HeartNet offers another therapeutic option that may improve the quantity and quality of life for our patients.”

According to the American Heart Association, heart failure is the leading cause of hospital admissions in the U.S., with more than 300,000 people dying from the disease annually.

Early findings show that HeartNet appears to improve cardiovascular function and exercise capacity in patients with an advanced stage of heart failure called dilated cardiomyopathy, a condition in which the heart becomes weakened and enlarged, reducing its ability to pump blood efficiently.

Implantation of the HeartNet device takes about one hour to perform and is done through a small incision in the chest. There are 30 U.S. and four Canadian medical centers investigating the effectiveness of the HeartNet device as part of the PEERLES-HF study.

The HeartNet, device was developed and is manufactured by Paracor Medical Inc., Sunnyvale, CA, the sponsor of the PEERLESS-HF trial.

For more information on the PEERLESS-HF trial and the HeartNet™, or to learn how you can participate, call 1-866-344-0628 or go to www.bigheartstudy.com.

HeartNet

Inova Health System is a not-for-profit healthcare system based in Northern Virginia that consists of hospitals and other health services, including emergency- and urgent-care centers, home care, nursing homes, mental health and blood donor services, and wellness classes. Governed by a voluntary board of community members, Inova’s mission is to improve the health of the diverse community it serves through excellence in patient care, education and research. Inova provides a healthy environment for its patients, families, visitors, staff and physicians by prohibiting tobacco use on its campuses.