New Device for Treatment of CHF Successfully Implanted in First Human Patient
April 14, 2009 - Symphony Medical Inc. announced today that its patented technology, Algisyl-LVR, was used on a human for the first time, successfully treating a 50-year-old male who was suffering from chronic heart failure.
The first procedure was performed at the German Heart Center in Munich, and the company plans to sponsor a clinical study of Algisyl-LVR at three other centers in Europe. The company will also pursue an Investigational Device Exemption from the U.S. FDA 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.
Prof. Dr. Robert Bauernschmitt successfully treated the first Algisyl-LVR patient during surgery to repair a poorly performing heart mitral
"We are extremely pleased with the initial outcome of the first patient treatment with Algisyl-LVR. The administration of this implantable biopolymer to the heart wall provides a practical new tool to prevent and even reverse the dilation of the left ventricle, which is typical in congestive heart failure. As such, this new therapy has the potential to provide significant health benefits to a growing population of patients.
While it is still very early, the initial outcome of Algisyl-LVR suggests that the therapy is feasible and safe while it provides immediate, tangible benefits. We look forward to treating additional patients here at the German Heart Center," said Prof. Dr. Bauernschmitt.
For more information: www.symphonymed.com.