European Trials Commencing for Injectable Biopolymer to Repair Weakened Heart Wall
LAGUNA HILLS, Calif., April 14 /PRNewswire/ -- Symphony Medical, Inc., a developer of novel biopolymer therapies to cardiac abnormalities, announced today that its patented flagship technology, Algisyl-LVR(R), was used on a human for the first time, successfully treating a 50-year-old male who was suffering from chronic heart failure.
The Company intends to sponsor a clinical study of Algisyl-LVR at four centers in Europe, including the German Heart Center in Munich where the first procedure was performed, and is also seeking an Investigational Device Exemption from the U.S. Food and Drug Administration in order to conduct a follow-on U.S. study.
Algisyl-LVR is an implantable medical device under clinical development intended to prevent or reverse the progression of congestive heart failure in patients who have an enlarged left ventricle. The procedure, which is performed on patients undergoing a planned cardiac surgery for mitral valve regurgitation or coronary artery disease, involves injecting a proprietary biopolymer directly into strategic locations of the heart's left ventricle wall. As it is injected, the biopolymer thickens and forms firm, gel-like structures that remain in the heart muscle as permanent implants. These implants act to re-shape the heart, reduce the size of the dilated left ventricle and thicken the damaged wall of the heart, thus returning the heart to a healthier form that facilitates improved cardiac function and performance.
The first Algisyl-LVR patient was successfully treated by Prof. Dr. Robert Bauernschmitt. The condition of the patient, who had been bedridden, was deteriorating due to a poorly performing heart mitral valve which contributed to congestive heart failure. During the surgery to repair the valve, the cardiac surgeon implanted the Algisyl-LVR. Four days following
|SOURCE Symphony, Medical Inc.|
Copyright©2009 PR Newswire.
All rights reserved