April 20, 2009 - Symphony Medical Inc. said last week its Algisyl-LVR biopolymer 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. It is also seeking an investigational device exemption from the 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 reshape the heart, reduce the size of the dilated left ventricle and thicken the damaged wall of the heart. The company said this helps return the heart to a healthier form that facilitates improved cardiac function.
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 the procedure, the patient's ejection fraction more than doubled, the size of his ventricle was reduced by 22 percent and his ventricle wall thickness increased by 23 percent. By day eight, the patient was able to walk unassisted. He was subsequently discharged from the hospital in a considerably improved condition, the company said.
"We are extremely pleased with the initial outcome of the first patient treatment with Algisyl-LVR,” said Prof. Dr. Bauernschmitt. 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."
The company has two products in its late-stage development pipeline. The first is Algisyl-LVR for the treatment to prevent or reverse the progression of chronic heart failure and mitral valve regurgitation. Symphony’s approach involves implanting a space-occupying biocompatible polymer into strategic areas of the heart’s left ventricle (LV) wall to affect LV shape and prevent or reverse LV enlargement. The company said reshaping and thickening the LV wall reduces wall stress, reduces mitral valve regurgitation and provides lasting improvement of cardiac function. Plexisyl-AF is a prophylactic method of preventing sustained post-operative atrial fibrillation, a common side effect in coronary bypass and cardiac valve replacement surgeries. Plexisyl has advanced to human clinical stage testing. A 32-patient safety study was completed in Europe in May 2008.
For more information: www.symphonymed.com