Algisyl®, LoneStar Heart's device for the treatment of heart failure patients with a dilated left ventricle, has not been globally approved for sale and can only be accessed by physicians and patients through company-sponsored clinical studies except for in Europe. Algisyl® received CE mark approval in October 2014 and can be sold in the European Union.
LoneStar Heart, Inc. has completed recruitment of patients into the AUGMENT-HF trial and is in the follow up phase of this study. This trial is a controlled, randomized clinical study to evaluate the safety and effectiveness of Algisyl® in patients with heart failure who have a dilated cardiomyopathy of either ischemic or non-ischemic origin. The study enrolled 78 patients from Italy, Germany, Romania, the Netherlands and Australia.
LoneStar Heart frequently commences and completes clinical trials, so please check back here often for news on new and existing trials worldwide. If you are interested in learning more about ongoing or future clinical studies please check back on this website at a later date. You can also review the relevant information at the ClinicalTrials.gov website maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). This website provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.
Specific information regarding the Algisyl® AUGMENT-HF trial can be obtained by accessing: http://clinicaltrials.gov/show/NCT01311791