ATLANTA, Sept. 26, 2019 /PRNewswire/ -- CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced it has completed enrollment of the adult arm of its FDA early feasibility IDE study for the Cor® TRICUSPID ECM®cardiac valve* for adults with endocarditis and for pediatric patients with congenital heart valve disease. 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 is a next generation, first of its kind, biologic, seamless, and stent-less cardiac valve composed of extracellular matrix or ECM®.
"This adult patient's case was special in that there were several congenital anomalies present. The diseased tricuspid valve required replacement and the perfect replacement was the CorMatrix Cor® TRICUSPID valve, in that it provides normal valve function and has the potential to remodel into the patient's own tissue. We are very involved with this ECM® technology on a regenerative basic science level and we are hopeful it will provide a better alternative valve," said Dr. Frank Scholl, Chief of The Heart Institute at Joe DiMaggio Children's Hospital in Hollywood, Florida.
"The conclusion of the early feasibility study is an important achievement for the CorMatrix Cor® TRICUSPID valve technology and for all valve surgery. I often refer to valve replacement as trading diseases, and it is the reason we strive to repair valves, instead of replace them. We alleviate the native valve pathology but leave the patient with a new problem, a prosthetic valve. For patients with unrepairable valve disease, the advent of a valve replacement that allows for native tissue ingrowth signals the opening of the next era of valve therapy," said Dr. Marc W Gerdisch, Chief of Cardiothoracic Surgery at Franciscan Health Heart Center in Indianapolis, Indiana & principal investigator for the adult component of the CorMatrix Cor® TRICUSPID IDE safety and feasibility clinical trial.
"CorMatrix® is very excited to complete enrollment of the adult arm of its FDA early feasibility IDE study for the Cor® TRICUSPID ECM® valve. This is just one step closer to ultimately providing biologic valve technology to an ever expanding patient need. The Cor® TRICUSPID ECM® valve joins a developing CorMatrix® pipeline of next generation ECM® biologic valve products for replacement and repair, designed for open surgical and percutaneous minimally invasive procedures," 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.
*Cor® TRICUSPID ECM® valve is an investigational device and not commercially available.