LoneStar Heart, has received the CE Mark (Conformite Europeene) for its Algisyl-LVR hydrogel implant, the company's lead product for the treatment of advanced heart failure (HF). Classified in Europe and in the US as a medical device, Algisyl-LVR is intended to reverse HF progression in people who have an enlarged left ventricle. Surgically injected directly into the heart muscle, the hydrogel acts immediately as an internal scaffold that does not undergo long-term degradation and increases cardiac output.
The CE Mark indicates a product's compliance with European Union legislation and that it can be sold throughout the European Economic Area. Six-month patient outcome studies of Algisyl-LVR will be presented at the annual meeting of the American Heart Association (AHA), November 15-19, 2014 in Chicago.
"CE Marking is a major milestone our clinicians have worked hard to achieve," said Frank Ahmann, LoneStar Heart's president and chief operating officer. "Thanks to them, 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. To date, 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 randomised clinical trial of Algisyl-LVR at the upcoming AHA meeting in November."
The AUGMENT-HF randomised clinical trial is being conducted at 14 centres in Italy, Germany, Romania, Australia, and The Netherlands to determine if the product is superior to standard medical therapy in the management of patients with a dilated and weakened left ventricle and significantly deteriorated cardiac function.
As reported last November 2013 at the American Heart Association annual meeting in Dallas, interim results of the study showed left ventricle augmentation of the failing heart after implantation with Algisyl-LVR can be performed safely in patients with advanced heart failure and provides functional improvement in their health status. Extensive preclinical studies have shown Algisyl-LVR decreases cardiac wall tension, while it improves heart muscle contractility and oxygen uptake, leading to a decrease in ventricle stress and to a marked cardiomechanic improvement.
Advanced HF represents a significant and growing epidemic healthcare burden in all developed countries. Of the more than 12 million patients affected in the North America and in Western Europe, about a third have significant limitations of physical activity while half die of heart failure within five years of diagnosis. A wide number of patients whose heart muscle is initially damaged by infarcts, hypertension, valve disease, or other processes lose the ability to pump blood efficiently to the body. 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 out 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.