Medical Device Daily
At one point Symphony Medical (Laguna Hills, California) had plans to inject stem cells into the heart as a therapy to cardiac abnormalities. The plan was daunting, and at the time seemed ideal. But placement of a biopolymer on the heart's left ventricle proved to be not only more effective, but also less cumbersome than using stem cells. The result of the switch was a therapy that promised results within hours of placement.
"We basically scrapped using [stem] cells," Ray Cohen CEO of Symphony told Medical Device Daily. "The placement of this biopolymer gave us an immediate response. It took us literally hours to see a change in the heart's functionality."
Cohen said the initial tests were in animal models. He added that the biopolymer had strong durability and continued to hold steady in those same models.
The biopolymer is called the Algisyl-LVR and the company will sponsor a clinical study of the treatment at four centers in Europe including the German Heart Center (Munich, Germany) where the first procedure was performed, and is also seeking an Investigational Device Exemption from FDA in order to conduct a follow-on U.S. study. The clinical study in Europe is looking for up to 18 patients and will wrap up in a matter of months Cohen said.
To date a 50-year-old man has been the first to be exposed to the treatment, and this patient has had some very good outcomes.
"Our first human subject was treated with the polymer and it was successful, there were no adverse events," Cohen said. "Before the treatment the patient had been bed ridden. After the treatment, by day eight, he was up and mobile."
He was subsequently discharged from the hospital in a considerably improved condition.
The condition of the patient was also 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, a measure of the heart's pumping ability, more than doubled, the size of his ventricle was reduced by 22% and his ventricle wall thickness increased by 23%.
"As one might imagine, the physician, the patient, and all of us at Symphony are quite energized with this remarkable result. Algisyl-LVR results from years of research and an exhaustive number of pre-clinical studies which demonstrated safety and impressive efficacy. Given that congestive heart failure is a lethal and complex disease, positive pre-clinical data does not always translate into success with humans; however, it is notable that there was an excellent correlation between our pre-clinical data and the first human results. We look forward to treating more patients and establishing Algisyl-LVR as an important new therapy to increase the quality of life of patients suffering from congestive heart failure."
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. Specifically it reshapes and thickens the LV wall which reduces wall stress, reduces mitral valve regurgitation and provides lasting improvement of cardiac function with an associated improvement in the patient's clinical status and quality of life.
The company has another product in its late-stage development pipeline - Plexisyl-AF a prophylactic method of preventing sustained post-operative atrial fibrillation (POAF), a common side effect of the nearly 1 million coronary bypass and cardiac valve replacement surgeries performed each year. Plexisyl has advanced to human clinical stage testing. A 32-patient safety study was completed in Europe in May 2008.