21 November 2014

Hydrogel will help with heart failure

Hydrogel implant helps to increase cardiac output

HospiMedicaImplantable hydrogel may revolutionize the treatment of heart failure (HF) in people with an enlarged left ventricle, which loses the ability to pump blood efficiently.

The Algisyl-LVR implant is an injectable patented biopolymer designed to reverse the progression of HF by reducing pressure on the heart wall and improving the contractility of cardiac muscles and oxygen absorption, which leads to a reduction in the load on the ventricle and to cardiomechanical improvements. Injected directly into the strategic areas of the left ventricular muscle by 12-18 injections, the hydrogel thickens, forming viscous polymer bodies that remain in the muscles as permanent implants that reduce the load on the ventricular wall, increase pumping efficiency and mitigate further expansion and negative correction of the left ventricle.


Algisyl-LVR hydrogel implantation procedure (photo by LoneStar Heart).

Two versions of the product are being developed; the surgical version is intended for cardiac surgeons and comes as standard with a syringe and a set of custom needles to perform an injection either during a chest opening operation (in combination with other methods of intervention, such as bypass surgery or valve repair), or during an autonomous mini-thoracotomy operation. The second method of product delivery offers a minimally invasive procedure using a catheter, which can be performed by interventional cardiologists or other specialists in a standard laboratory or a hybrid cardiology laboratory.

Treatment does not interfere with drug therapy and regular treatment of HF patients, as it consists of a one-time passive procedure. After being injected directly into the heart muscle, the hydrogel immediately acts as an internal framework that does not undergo delayed degradation. A randomized clinical trial (AUGMENT-HF study) is being conducted in 14 centers around the world to determine the superiority of the development over standard drug therapy. Algisyl-LVR Hydrogel Implant is a product of LoneStar Heart (Laguna Hills, California, USA) and has received a CE mark of compliance with European Union standards.

"Patients will soon be able to receive revolutionary treatment to reduce the symptoms of moderate to severe heart failure and ensure an improvement in their clinical condition and quality of life," says Frank Ahmann, president and CEO of LoneStar Heart. "Our safety and efficacy results are consistently progressing in the right direction, and we look forward to presenting the results of our randomized AUGMENT–HF Algisyl-LVR trial at the American Heart Association meeting" (Chicago, November 15-19, 20014).

Progressive HF represents a significant and totally growing burden on healthcare in all developed countries, affecting patients whose heart muscle is initially damaged by heart attacks, hypertension, valve abnormality or other processes. To overcome the initial damage, the heart muscle works under increased tension without the possibility of recovery; eventually, the left ventricular muscle begins to stretch, and muscle cells lose the ability to contract normally. Therapeutic options for many such patients who do not respond to medications and therapeutic devices are limited and can be extremely complex and expensive.

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