First patient treated in LoneStar's AUGMENT-HF trial of Algisyl-LVR
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.