Laguna Hills, Calif.-based LoneStar Heart said it won CE Mark approval in the European Union for its Algisyl-LVR hydrogel implant for the treatment of advanced heart failure.
Algisyl-LVR is designed to reverse heart failure progression in patients with an enlarged left ventricle, according to a press release. Surgically injected directly into the heart muscle, the hydrogel acts as an internal scaffold that does not undergo long-term degradation and increases cardiac output, LoneStar Heart said.
"CE Marking is a major milestone our clinicians have worked hard to achieve," president & COO Frank Ahmann said in prepared remarks. "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."
LoneStar said it’s conducting a clinical trial at 14 centers in Italy, Germany, Romania, Australia and Holland 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.
Advanced heart failure affects more than 12 million patients in North America and Western Europe, with half dying of heart failure within 5 years of diagnosis, LoneStar said.