Algisyl LVR Implantable Biopolymer

Algisyl-LVR is a medical device under clinical development intended to prevent or reverse the progression of Advanced Heart Failure in patients who have an enlarged left ventricle as a result of a myocardial infarct, mitral valve regurgitation, ischemia, arrhythmias, and/or other disorders. The product consists of an injectable proprietary biopolymer (hydrogel) that is administered directly into strategic areas of the left ventricle muscle. 12-18 injections are made into the left ventricle wall, and the hydrogel thickens and forms gel-like bodies of polymer that remain in the heart muscle as permanent implants, acting to reduce left ventricular wall stress, increase pumping efficiency and mitigate further dilation and negative remodeling of the left ventricle.

Algisyl-LVR represents a new treatment strategy based on the medically accepted principle that a reduction in muscle tension and cell stress will improve the function of the dilated left ventricle of the heart. In both animal and human studies,  Algisyl hydrogel implantation within the ventricle muscle wall has been shown to relieve the muscle tension and wall stress of the dilated heart. These studies indicate not only significant improvements in pumping efficiency (the “ejection fraction”) and other cardiomechanical parameters, but also positive biological effects such as localized capillary and tissue regeneration.

Treatment with Algisyl-LVR does not interfere with drug therapies and the regular management of heart failure patients. It consists of a one-time procedure that can be conducted efficiently and cost-effectively. In contrast to active implantable devices that require a power source such as a battery, Algisyl-LVR is passive and requires minimal care following its implantation.

Two product versions are being developed that target different physician segments and will be marketed separately. In the surgical product version for cardiothoracic surgeons, the alginate is delivered in a standard syringe and custom needle system designed for surgeons to perform the injections either during open chest surgery in combination with other interventions such as bypass or valve repair, or through a stand-alone mini-thoracotomy operation. The second product delivery method offers a minimally invasive, catheter-based procedure that can be performed by interventional cardiologists and, in some isolated cases, other specialists in a standard or hybrid cardiology laboratory.

Please reference the following paper, published in Cell Transplantation, for more information about our first-in-man clinical trial.

Lee, R. J., Hinson, A., Helgerson, S., Bauernschmitt, R., & Sabbah, H. N. (2012). Polymer-based restoration of left ventricular mechanics. Cell Transplant. doi:10.3727/096368911X637461.