The first patient has been treated in LoneStar Heart's international multicentre AUGMENT-HF clinical trial of Algisyl-LVR at IRCCS San Raffaele Pisana and at Umberto I Policlinico, both located in Rome, Italy. The surgery was conducted by cardiac surgeon, Dr Fabio Miraldi, at Umberto I Policlinico.
The AUGMENT-HF clinical study follows on from the success of a pilot study at the German Heart Centre in Munich and Heart Centre Dresden that established the safety and feasibility of Algisyl-LVR in severe HF patients. AUGMENT-HF is a randomised, controlled, 76-patient clinical study designed to validate the clinical benefits of Algisyl-LVR for patients with severe heart failure (HF). The study is taking place in major hospitals in Italy, Australia, New Zealand, and the Netherlands. AUGMENT-HF patients will be followed over a two-year period. The primary endpoint to be measured at six months post-treatment is so-called "peak VO2" - the maximum amount of blood oxygen that the heart can provide to muscles during sustained physical activity. Although patient follow-up will continue for two years, LoneStar anticipates receiving CE clearance to market Algisyl-LVR in Europe in 2013. The company is also working with the FDA to allow for clinical evaluation and eventual marketing clearance in the US.
Classified as a medical device by the FDA and the EU, Algisyl-LVR is injected directly into strategic areas of the left ventricle muscle during surgery. As it is injected, the biopolymer thickens and forms gel-like bodies that remain in the heart muscle as permanent implants, providing internal support to the injured heart, reducing the ventricle's tension and stress, and preventing the progression of HF. Algisyl-LVR is not biologically active and it does not cause the body's immune system to reject it. It's ability to reduce heart muscle tension and cell stress appears to allow the heart's natural healing to not only stop the disease process, but actually shows signs of reversing it. LoneStar is testing the biopolymer to prevent or reverse the progression of HF in patients who have an enlarged left ventricle as a result of a heart attack, a valve malfunction, inadequate blood supply to the heart muscle, or other heart disorders.
In its current product version, the biopolymer is delivered through a small surgical incision in the chest in a beating heart procedure with a typical duration of less than 60 minutes. A second product version in development is expected to offer patients a procedure that can be performed by interventional cardiologists and other specialists in a non-invasive or hybrid cardiology laboratory.