CorMatrix Cardiovascular has received US FDA approval of an early feasibility study investigational device exemption (IDE) to evaluate the safety and feasibility of the Cor Tricuspid ECM cardiac valve for adults with endocarditis and for paediatric patients with congenital heart valve disease. A press release reports that the Cor Tricuspid ECM is the first cardiac valve of its kind composed of extracellular matrix or “ECM”.
According to the press release, the CorMatrix ECM has been used extensively and successfully in other cardiovascular applications in 220,000 plus implants. The Cor Tricuspid ECM valve IDE study will be conducted in up to eight clinical centres performing paediatric and adult cardiac surgery. The device joins a series of ECM products that will address clinical challenges in the cardiovascular disease market, which will eventually include regenerative solutions for congestive heart failure and paediatric and adult cardiac valve patients.
Robert G Matheny, chief medical & scientific officer, comments: “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.”
Edgar Rey, president & CEO, CorMatrix Cardiovascular, states: “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 paediatric patient applications. The Cor Tricuspid ECM valve joins a rapidly developing CorMatrix pipeline of next generation ECM products and patient solutions.”