Paris, France, May 1, 2017 — Prof. Andrew Coats of Monash and Warwick Universities presented today at a late breaking trials session of the Heart Failure 2017 congress the 18-month and 2-year follow-up results of the AUGMENT-HF trial. AUGMENT-HF is a multicentric randomized clinical study to evaluate the safety and efficacy of Algisyl, an implantable hydrogel for the treatment of Advanced Heart Failure. The results presented in Paris confirmed that the significant clinical benefits observed and published previously in patients treated with Algisyl in comparison to patients treated with optimal medical therapy were sustained throughout the 18- and 24-month marks. Specifically, NYHA function class, quality of life, and patient global assessment remained constant in the Algisyl® treatment arm and the number of heart failure hospitalizations remained lower than in the optimal medical therapy group. The results presented by Prof. Coats underscore the long term benefits of the single implantation procedure of Algisyl®.
BAMBRA mum Rhonda Armstrong was told she wouldn’t survive heart transplant and to start saying her goodbyes when she chanced upon a radical trial procedure which gave her another look at life.
Cardiomyopathy had blown the left side of her heart out to four times the size of a regular whole heart. Her specialist at Melbourne’s The Alfred hospital described it as being like a string bag which had lost its strength.
Remarkably, injection of an Algisyl solution derived from seaweed into the heart wall has made the lifetime horsewoman well enough to tackle the trek of a lifetime.
Editor Note: The Heart Center at the University of Gottingen is also issuing a press release to announce the AUGMENT-HF clinical trial results.
ORLANDO, Fla., November 11, 2015 — LoneStar Heart, Inc. today presented and published the one-year extended follow-up results of AUGMENT-HF, an international randomized, multi-center clinical trial to evaluate the safety and efficacy of Algisyl. Classified as a medical device, Algisyl is a novel hydrogel that is implanted into specific areas of the failing heart muscle to improve cardiac function and clinical symptoms in advanced heart failure patients. Algisyl is approved for use in the European Union. The U.S. Food and Drug Administration recently approved an Investigational Device Exemption that allows the company to initiate a pivotal clinical study of Algisyl in the United States subject to certain conditions. Read more
Dr. Stephan Anker from Charité Med. University, Berlin, Germany, speaking on behalf of LoneStar Heart reports additional positive 6 month data from the AUGMENT-HF trial at the American College of Cardiology meeting in San Diego, CA.
CHICAGO, November 18, 2014 — LoneStar Heart, Inc. today presented the primary six month results of its multicenter, randomized clinical trial of Algisyl-LVR® providing evidence that the cardiac hydrogel implant can prevent or reverse the symptoms of moderate to severe heart failure in patients with a dilated and weakened left ventricle. The improvement in clinical status and quality of life of the patients was consistent with reported data that demonstrates the cardiac hydrogel works by improving the failing heart’s structure and function. Read more
LAGUNA HILLS, Calif., October 1, 2014 — LoneStar Heart, Inc. today announced that it received the CE Mark (Conformité Européene) 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 U.S. 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. Read more
LAGUNA HILLS, Calif., May 5, 2014 — LoneStar Heart, Inc. today announced that it completed the patient recruitment phase of the company’s AUGMENT-HF controlled randomized trial of Algisyl-LVR hydrogel implant, its lead product for the treatment of advanced heart failure (HF). LoneStar Heart expects to present six-month outcomes by yearend.
The AUGMENT-HF clinical trial is being conducted at 14 centers 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. Read more
Laguna Hills, CA, January 8, 2014 – Algisyl-LVR®, an implantable hydrogel to treat advanced heart failure patients who have a dilated left ventricle, will be the subject of two scientific presentations at the 9th Conference on Cell Therapy for Cardiovascular Disease sponsored by the Cardiovascular Research Foundation in New York City on January 22-24, 2014.
Authored by Jay W. Schneider, MD, Ph.D., Assistant Professor at the Department of Internal Medicine- Cardiology at the University of Texas Southwestern Medical Center at Dallas, the first presentation describes ground-breaking research to identify the molecular and genomic events that contribute to the healing response when Algisyl-LVR® is delivered to the heart muscle. It is entitled “Mechanistic Insights from Alginate in Mouse Heart: Stealth Myocardial Engraftment and Molecular Signaling to the Cardiac Genome.” Read more
January 6, 2014 – In its latest web-based edition of EHJ TODAY INTERVIEWS, the European Heart Journal published by Oxford University Press features an interview with Douglas L. Mann, MD, Professor and Chief, Cardiovascular Division of Washington University School of Medicine, and Jean-Sebastien Hulot, MD, Assistant Professor Medicine, Cardiology, at The Mount Sinai Hospital in New York City. The moderator is Stefanie Dimmeler, MD, Ph.D., Professor of Cardiology at the Goethe University in Frankfurt, Germany. Read more
Results of Multicenter, Randomized Study Show Left Ventricle Augmentation with Hydrogel Implant Provides Functional Improvement in Health Status
DALLAS, November 20, 2013 — LoneStar Heart, Inc. today presented the interim results of its multicenter, randomized AUGMENT-HF clinical trial showing left ventricle augmentation of the failing heart with the company’s lead product, Algisyl-LVR hydrogel implant, can be performed safely in patients with advanced heart failure (HF) and provides functional improvement in their health status. The study is being conducted at 15 centers 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. Read more