A prospective study of the first 25 patients who had surgery to install the ring shows that it reduced the leakage of blood back through the mitral valve, which leads to the heart's main pumping chamber. But it also changed the shape of that chamber, called the left ventricle, helping its muscular walls contract and pump blood better.
All 25 patients had mitral valve regurgitation (leakage) as a result of distorted left ventricles, and were experiencing severe symptoms, before having surgery to install the ring. All experienced great improvement in their symptoms, and lived at least a month after the operation. All but two were still alive six months after surgery.
The ring was co-invented by Steven Bolling, M.D., the University of Michigan Cardiovascular Center cardiac surgeon who presented the results on behalf of the research team, and by Italian cardiac surgeon Ottavio Alfieri of the St. Raffaele Hospital in Milan. The ring is made of titanium and silicone rubber.
The technology was licensed to Edwards Lifesciences Corporation for development and commercialization, and will be marketed as the GeoForm mitral valve repair ring. Both the co-inventors and the U-M stand to benefit financially from the device's sale.
The GeoForm ring has been approved by the U.S. Food and Drug Administration for use in tightening leaky mitral valves. But the new data are the first indication that it also re-shapes the left ventricle, which often becomes distended and misshapen after a heart attack or infection attacks the heart muscle. Nearly 5 million Americans have congestive heart failure, and the number is expected to
Contact: Kara Gavin or Sally Pobojewski
University of Michigan Health System