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First U.S. Patients Receive New Heart Therapy Device

COLUMBUS, Ohio – A West Virginia man and a central Ohio man are the first in the United States – and only the sixth and seventh worldwide – to receive an implant designed to treat moderate heart failure by strengthening cardiac output. The procedures were performed at the Ohio State University Medical Center on April 15 and 16.

As part of a multi-center trial, led in part by Ohio State University, a cuff is surgically wrapped around the patient’s aorta, which is the main blood vessel that distributes blood throughout the body.

Using a heart signal sensing wire, the cuff rapidly inflates and deflates to assist the pumping action of the heart. Although it is implanted during an open chest procedure, an advantage of this therapy is that it avoids blood contact, which limits complications and allows for faster recovery time. Patients may go home within a few days of device implantation.

“Patients with moderate heart failure experience symptoms such as shortness of breath and fatigue during mild exercise,” says Dr. Benjamin Sun, chief of cardiothoracic surgery at Ohio State’s Richard M. Ross Heart Hospital, who implanted the devices. “The concept of this therapy is to improve blood supply to the body and heart muscle to avoid further progression of the condition.”

When the heart is filling with blood, a balloon inside the device inflates to push blood out of the aorta to the rest of the body and to the heart muscle itself. Just before the heart pumps blood out, the device deflates to open up the aorta, reducing aortic pressure and the heart’s workload.

“This device holds promise for those who remain substantially symptomatic despite treatment with currently available drugs and devices,” said Dr. William T. Abraham, director of the division of cardiovascular medicine at Ohio State’s Medical Center and national co-lead principal investigator. “We are studying its effectiveness in improving how patients feel and their ability to perform activities of daily living.”

According to Abraham, heart failure occurs when a patient’s heart is not pumping blood efficiently, most often due to a weak heart muscle damaged by a prior heart attack or some other cause. More than five million U.S. adults suffer from heart failure, with an estimated 500,000 new cases each year.

OSU Medical Center, a leading center for heart failure and interventional research, is one of six centers participating, and the only one in Ohio, in the FDA-approved safety and feasibility study. Dr. David Feldman, director of heart failure and cardiac transplantation at Ohio State, is the local lead principal investigator.

C-Pulse was developed by Sunshine Heart, Inc., Tustin, CA. The study is funded by Sunshine Heart, Inc. Abraham is a paid consultant for the company.

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