CorMatrix Cardiovascular, Inc., a leading developer of biomaterials and medical devices, today announced treatment of the first patient to receive their tissue engineered regenerative CorMatrix® ECM® Tricuspid Valve. The operation was performed by Marc Gerdisch, MD, FACS, FACC, Chief of Cardiovascular and Thoracic Surgery at Franciscan St. Francis Health in Indianapolis. The Company received approval for the CorMatrix® ECM® Tricuspid Heart Valve as an early feasibility study approved through the FDA Investigational Device Exemption (IDE). The trial will demonstrate proof of principle and initial clinical safety of the CorMatrix® ECM® Tricuspid Valve at 8 US centers. The study will enroll up to 15 patients who are candidates for the surgical management of tricuspid valve disease not amenable to annuloplasty or repair; including tricuspid valve disease secondary to congenital heart disease in pediatric patients (age < 21) and adult patients with tricuspid endocarditis.
In addition to Franciscan St. Francis Health, other clinics participating in the study include the Mayo Clinic (Rochester, MN), Cincinnati Children’s Hospital (Cincinnati, OH), Cleveland Clinic (Cleveland, OH), Duke University (Durham, NC), Florida Hospital (Orlando, FL), Nationwide Children’s Hospital (Columbus, OH), and the University of Iowa (Iowa City, IA). The Principal investigator for the study is Dr. Joseph Dearani, Chair, Division of Cardiovascular Surgery at the Mayo Clinic.
Dr. Gerdisch is the first surgeon globally to use the tricuspid device in the study. “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,” said Dr. Gerdisch. “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 first FDA study enrollment is a substantial step toward patients avoiding synthetic replacement valves by having the opportunity to regrow their own.”
The CorMatrix® ECM® Tricuspid Valve is a flexible, unstented valve constructed from the CorMatrix® ECM® material. The device is specifically designed to function immediately after implantation as a competent heart valve and to perform efficiently at lower transvalvular pressure gradients as experienced by the normal tricuspid valve. CorMatrix’s unique bioscaffold characteristics enable native cells to infiltrate and remodel over time into a fully functioning tricuspid valve. The implanted, remodeled valve is comprised of the patient’s own tissue and leaves behind no “foreign body” as is the case with all mechanical or prosthetic valve designs. In addition, the CorMatrix® ECM® Tricuspid Heart Valve does not require the long-term anticoagulation therapy associated with the implant of mechanical valves.
Other unique features of the device include: mechanical resemblance to the native tricuspid valve, conformity of the normal annulus rather than a stiff prosthetic, maintenance of the subvalvular connection to the right ventricle, ability of the device to become lined with native endothelium during remodeling, and ease of surgical implantation.1 In an ovine model, tubular SIS-ECM TV bioprostheses demonstrated “growth”.2
Valve diseases affect up to 5 million Americans each year3 and while some types are not serious, others can lead to major complications including death. When valve disease is severe, it may be necessary to repair or replace the diseased valve. There are no valves on the market that have been specifically designed for adult and pediatric tricuspid replacement. Lack of availability of FDA-approved products for the tricuspid valve has resulted in non-indicated devices being used to replace irreparable valves in adult and younger patients. In pediatric patients, some are left with limited or no surgical repair options.
CorMatrix Chief Executive Office, David Camp commented, “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.”