CorMatrix Cardiovascular has announced FDA approval of an early feasibility study IDE to evaluate the safety and feasibility of the Cor TRICUSPID ECM cardiac valve for adults with endocarditis and for pediatric patients with congenital heart valve disease.
Image: CorMatrix Cardiovascular has secured FDA IDE approval to conduct safety and feasibility clinical trial of the Cor TRICUSPID ECM valve for pediatric and adult patients. Photo: courtesy of krishna arts / FreeDigitalPhotos.net.
The Cor TRICUSPID is the first cardiac valve of its kind composed of extracellular matrix or ECM. The CorMatrix ECM has been utilized 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 8 clinical centers performing pediatric and adult cardiac surgery.
The Cor TRICUSPID 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 pediatric and adult cardiac valve patients.
“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,” said Robert G Matheny, MD Chief Medical & Scientific Officer.
“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 CorMatrixpipeline of next generation ECM products and patient solutions,” said Edgar Rey, President & CEO, CorMatrix Cardiovascular Inc.
CorMatrix Cardiovascular, Inc. is a regenerative biotechnology company based in metro Atlanta, Georgia. A pioneer and leader in regenerative science and technology, the company was founded to address congestive heart failure, the largest global disease management challenge and unmet cardiovascular clinical need.
CorMatrix provides regenerative, technological innovations, and patient solutions for the treatment of congestive heart failure and other cardiovascular diseases. The company is committed to developing innovative future non-synthetic, regenerative devices for the cardiovascular system through continued research and improvements to the CorMatrix ECM technology.
Source: Company Press Release