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Wake Forest University Start-Up Wins FDA Approval for Heart Device

WINSTON-SALEM, N.C. – A new high-technology medical device used with MRI scanners that helps doctors watch the beating heart has been approved by the U.S. Food and Drug Administration.

S. Scott Huber, president of MRI Cardiac Services Inc., said the device, called CardioVue, “is particularly useful in emergencies due to its rapid real time capabilities.”

MRI Cardiac Services is a start-up company of Wake Forest University Health Sciences (WFUHS).

“CardioVue gives the physician a unique tool to assist him in doing a real-time evaluation of the cardiac system of the patient,” Huber said. “A key advantage of CardioVue is that it is designed to take a large volume of raw cardiac magnetic resonance images and transform them into meaningful and actionable diagnostic information.”

Michael A. Batalia, Ph.D., director of the WFUHS Office of Technology Asset Management, said, “We are excited to see CardioVue transition out of the laboratory and into clinical practice. This technology has the potential to dramatically change the way physicians manage their cardiovascular patients."

Cardiac magnetic resonance images are downloaded directly from an MRI scanner to CardioVue, where they are displayed and synchronized for rapid viewing, manipulation and analysis by physicians, said Huber.

CardioVue allows the doctor to view and compare the heart from multiple angles to pick up motion abnormalities in the wall of the heart. These abnormalities might indicate that a heart attack has occurred or is in progress or that the heart is otherwise not receiving enough oxygen due to narrowing of the coronary arteries that feed blood to the heart wall.

CardioVue also can be used during drug-induced stress tests. Cardiac stress testing is necessary for the accurate diagnosis of coronary artery disease but exposes the patient to risk of a coronary event.

“The real time visualization and analysis capabilities of CardioVue enable doctors to closely monitor the patient during the test to ensure their safety,” Huber said. “This is the first device developed for this purpose.”

CardioVue also helps doctors to rapidly calculate the volume of blood that is pumped out by the left ventricle during one beat of the heart, called the ejection fraction. “The measurement of a patient’s ejection fraction is a widely used means of determining the mechanical efficiency of the heart muscle,” he said. A low ejection fraction combined with observed wall motion abnormalities serve to confirm the doctor’s diagnosis.

MRI Cardiac Services will now begin marketing the device.

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Media Contacts: Robert Conn, rconn@wfubmc.edu, Shannon Koontz, shkoontz@wfubmc.edu, or Karen Richardson, krchrdsn@wfubmc.edu, at (336) 716-4587.

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine and its other related enterprises including the Piedmont Triad Research Park. The Medical School is ranked 4th in the Southeastern United States in revenues from its licensed intellectual property.


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