CorMatrix Cardiovascular said today that it launched a trial of its Cor Tricuspid ECM cardiac valve intended for treating adults with endocarditis and pediatric patients with congenital heart valve disease, adding that the first patient in the trial has already been treated.
The first procedure in the trial took place at the Francicscan Health Heart Center by a team led by Dr. Marc Gerdisch, Atlanta-based CorMatrix said. The patient, who was suffering from endocarditis, has returned home and is recovering well, the company added.
“This first FDA study enrollment is a substantial step toward patients avoiding synthetic or animal tissue replacement valves, by having the opportunity to regrow their own tissue. We have been using CorMatrix for eight years with exceptional success in reconstructing complex structures of the heart and blood vessels. Given the remarkable adaptability and regenerative properties of CorMatrix, this new valve structure will have a dramatic effect on surgery for tricuspid valve pathology, especially for younger patients. Furthermore, it serves as a platform for engineering other heart valves,” Dr. Gerdisch said in a prepared statement.
CorMatrix touts its Cor Tricuspid ECM cardiac valve as the first cardiac valve of its kind to be composed of an extracellular matrix, and said that its CorMatrix ECM material has been used in more than 220,000 cardiac implants to date.
“This important step for our patients and CorMatrix, to create a valve that will mimic in all respects a normal valve is no easy task, but the technology and our ability to harness the regenerative potential continues to improve,” chief medical and scientific officer Dr. Robert Matheny said in a prepared staetment.
“The Cor Tricuspid ECM valve is the first seamless ECM cardiac valve approved by the FDA for an IDE safety and feasibility clinical trial for adult and pediatric patient applications. We are very pleased to be working with Dr. Gerdisch and through his leadership, with the team at Franciscan Health Heart Center on this important study. The Cor Tricuspid ECM valve joins a rapidly developing CorMatrix pipeline of next generation ECM products and patient solutions,” prez & CEO Edgar Rey said in a press release.
Last month, CorMatrix said that it won FDA investigational device exemption approval to launch an early feasibility study of the Cor Tricuspid ECM cardiac valve.