CorMatrix Cardiovascular said today it enrolled the 1st patient in a trial of its CorMatrix ECM tricuspid valve designed from regenerative tissue.
The early feasibility trial aims to demonstrate proof of principle and initial clinical safety at 8 U.S. centers, the Roswell, Ga.-based company said. CorMatrix is performing the trial under an investigative device exemption from the FDA.
“The treatment of the first patient in our study represents a major milestone for CorMatrix and strengthens our leadership in the field of regenerative medicine. This study actively addresses the need for a tricuspid valve replacement that improves clinical outcomes in pediatric and adult patients who may not otherwise have an option. The development of this application of CorMatrix ECM Technology truly has the capacity to lengthen people lives and furthers our pursuit of developing the best possible medical devices for surgeons and the patients they treat,” CEO David Camp said in a press release.
The 1st operation was performed by Dr. Marc Gerdisch of Indianapolis, Ind.’s Franciscan St. Francis Health, the company said.
“The past decade has seen an enormous expansion of research in, and subsequently—understanding of extracellular matrix. We have been using CorMatrix for 8 years with remarkable success in reconstructing complex structures of the heart and blood vessels. In 2014, we published the North American experience with complete CorMatrix tubular reconstruction of the tricuspid valve. Given the remarkable adaptability and regenerative properties of CorMatrix we recognized the dramatic effect this could have on surgery for tricuspid valve pathology, especially for younger patients. Furthermore, it would serve as a platform for engineering other heart valves. This 1st FDA study enrollment is a substantial step toward patients avoiding synthetic replacement valves by having the opportunity to regrow their own,” Dr. Gerdisch said in prepared remarks.
The study is slated to enroll up to 16 patients who are candidates for surgical management of their tricuspid valve disease that is not amenable to annuloplasty or repair.
The ECM tricuspid valve is a flexible, unstented valve designed from the company’s CorMatrix ECM material. The device was manufactured to function immediately after implantation as a competent heart valve, the company said, and to perform efficiently at lower transvalvular pressure gradients than standard tricuspid valves.
Early last month, CorMatrix said it won FDA 510(k) clearance for its Tyke biomaterial for use in neonates and infants.
The patch is designed to repair pericardial structures and as an epicardial covering or for intracardiac defects, septal defects, annulus repair, suture-line buttressing.
The Tyke is derived from the company’s ECM technology platform and is composed of 2 layers of ECM, as opposed to 4 layers in their standard cardiac tissue repair patches, making it thinner for smaller repairs.