UNT HEALTH SCIENCE CENTER LICENSES CARDIAC ASSIST DEVICE

March 27, 2001

FORT WORTH, Texasâ?? Researchers at the University of North Texas Health Science Center have developed a new tool for heart surgeons and cardiologists that potentially will support circulation following heart surgery or heart attacks better than devices currently in use.

The “Enhanced Intra-Aortic Balloon Assist Device” is specifically designed to maintain the aortic blood pressure at an adequate level by overcoming limitations of current devices. The U.S. Patent Office approved the device February 20, 2001, (Patent No. 6,190,304 B1). UNT Health Science Center has licensed exclusive worldwide rights to the device to Cardiac Surgical Devices, Inc., a privately held start-up company based in Irvine, California. In exchange, the health science center has acquired 20 percent of the companyâ??s outstanding stock.

Currently, cardiologists or cardiac surgeons use regular intra-aortic balloon assist devices to reduce the heartâ??s workload and improve flow of blood to a patientâ??s brain, heart, and other vital organs. These pumps may not provide adequate circulatory support for patients with severely diseased or injured hearts.

Xiaoming Bian, M.D., Ph.D., and H. Fred Downey, Ph.D., researchers with the health science centerâ??s Cardiovascular Research Institute, invented the Enhanced Intra-aortic Balloon Assist Device to improve blood flow and provide circulatory support when pressures fall below those required by currently available devices. The device adds an external pumping module that works in series with an internal pump in cases where conventional intra-aortic balloon pumps are unable to maintain adequate blood flow.

“This device has the potential to provide additional support for patients with failing hearts,” said Dr. Downey, who has studied coronary circulation for more than 30 years. “Results from our initial prototype testing and simulation studies have been very promising.”

Further, Dr. Downey anticipates that the device will be specified for most conditions that require circulatory support, so that its reserve pumping capacity will be available, even if the patientâ??s aortic blood pressure is initially high enough to use a regular device.

“We are delighted to be working with the health science center and intend to proceed quickly to clinical trials in order to obtain FDA approval,” said James E. Ryan, chief executive officer of Cardiac Surgical Devices, Inc.

According to the Centers for Disease Control and Prevention, congestive heart failure is the single most frequent cause of hospitalization for people aged 65 years or older, and heart disease is the leading cause of premature, permanent disability among working adults.

The Cardiovascular Research Institute was established in 1995 as an Institute of Discovery of the UNT Health Science Center. It is a multidisciplinary program designed to promote basic and clinical research, education, clinical practice and community outreach programs in the prevention, diagnosis, treatment and rehabilitation of cardiovascular disease.

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