CorMatrix Cardiovascular said today that it won FDA investigational device exemption approval to launch an early feasibility study of its Cor Tricuspid ECM cardiac valve intended for treating adults with endocarditis and pediatric patients with congenital heart valve disease.
The Atlanta-based company touts its Cor Tricuspid valve as the first cardiac valve of its kind to be composed of an extracellular matrix, and said that its CorMatrix ECM 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 & scientific officer Dr. Robert Matheny said in a prepared statement.
CorMatrix said that the study will be conducted at eight clinical centers and will include both adult and pediatric patients.
“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. 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.
In July 2016, CorMatrix said that it won CE Mark approval in the European Union for its CanGaroo ECM surgical envelope for implanted cardiac devices.