First Patient Successfully Treated With Algisyl-LVR Device

Symphony Medical, a developer of novel biopolymer technologies for cardiac disorders, has successfully used its flagship Algisyl-LVR technology to treat their first human patient.

Over five million people in the U.S. suffer from chronic heart failure and mitral valve regurgitation. Algisyl-LVR is an implantable device intended to prevent or reverse these conditions in patients who have an enlarged left ventricle. The implantation procedure involves injecting a proprietary biopolymer into specific regions of the left ventricle wall. The biopolymer thickens upon injection, forming permanent, gel-like implants that remain within the heart muscle. These implants act to reshape the heart, reducing the size of the left ventricle and thickening the heart’s damaged wall, thus improving cardiac function.

The 50-year-old patient, who was bedridden, was treated at the German Heart Center in Munich. His condition was deteriorating due to a poorly performing mitral heart valve that contributed to his congestive heart failure. Four days after the implantation of Algisyl-LVR, his heart’s ability to pump blood more than doubled. Left ventricle size decreased by 22 percent, and the thickness of his ventricle wall increased by 23 percent. After eight days, the patient could walk unassisted. His condition had improved considerably by the time he was discharged from the hospital.

Symphony Medical intends to sponsor a clinical study of Algisyl-LVR at four centers in Europe, including the German Heart Center. The company is also seeking an exemption from the U.S. Food and Drug Administration to conduct a U.S. study. Symphony Medical is concurrently developing Plexisyl-AF, which targets post-operative atrial fibrillation, a common side effect of coronary bypass and cardiac valve replacement surgeries. A 32-patient safety study was completed in Europe last year.

Related video: Raymond W. Cohen, CEO of Symphony Medical.

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