Hydrogel Implant Helps Increase Cardiac Output

The Algisyl-LVR implant is an injectable proprietary biopolymer intended to reverse HF progression by decreasing cardiac wall tension and improving heart muscle contractility and oxygen uptake, thus leading to a decrease in ventricle stress and to cardiomechanical improvement. Administered directly into strategic areas of the left ventricle muscle in 12–18 injections, the hydrogel thickens to form viscous bodies of polymer that remain in the muscle as permanent implants, reducing ventricular wall stress, increase pumping efficiency, and mitigating further dilation and negative remodeling of the left ventricle.

Two versions are being developed; a surgical product version intended for cardiothoracic surgeons, which is delivered in a standard syringe and custom needle system for performing 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 or other specialists in a standard or hybrid cardiology laboratory.

The treatment does not interfere with drug therapies and the regular management of HF patients, since it consists of a one-time passive procedure. Once injected directly into the heart muscle, the hydrogel acts immediately as an internal scaffold that does not undergo long-term degradation. A randomized clinical trial (the AUGMENT-HF study) is underway in 14 centers worldwide to determine superiority to standard medical therapy. The Algisyl-LVR Hydrogel Implant is a product of LoneStar Heart (Laguna Hills, CA, USA), and has received the European Community CE marking of approval.

“Patients may soon have a revolutionary treatment to reduce the symptoms of moderate to severe heart failure and provide improvement in their clinical status and quality of life,” said Frank Ahmann, president and CEO of LoneStar Heart. “Our safety and efficacy results are consistently trending in the right direction, and we are looking forward to presenting the results of our AUGMENT-HF randomized clinical trial of Algisyl-LVR at the upcoming AHA meeting.”

Advanced HF represents a significant and growing epidemic healthcare burden in all developed countries, affecting patients whose heart muscle is initially damaged by infarcts, hypertension, valve disease, or other processes. To overcome the initial damage, the heart muscle works under increased stress without an opportunity to recover; eventually, the muscle of the left ventricle begins to stretch and the muscle cells lose the ability to contract normally. The therapeutic options for many of these patients who do not respond to drug and device therapies are limited and can be extremely complex and costly.

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