According to CorMatrix, a patient has become the first person to receive the company’s tissue-engineered regenerative tricuspid valve. The operation was performed by Marc Gerdisch (Franciscan St Francis Health, Indianapolis, USA), who was implanting the valve as part of CorMatrix’s investigational device exemption (IDE)-feasibility study of the device. The aim of the FDA-approved trial is to demonstrate proof of principle and initial clinical safety of the CorMatrix ECM tricuspid valve.
A press release reports that the study will enrol 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 paediatric patients (age <21) and adult patients with tricuspid endocarditis.
In addition to Franciscan St Francis Health, other US clinics participating in the study include the Mayo Clinic, Cincinnati Children’s Hospital, Cleveland Clinic, Duke University, Florida Hospital, Nationwide Children’s Hospital, and the University of Iowa. The principal investigator for the study is Joseph Dearani (Division of Cardiovascular Surgery, Mayo Clinic, Rochester, USA).
Gerdisch was the first surgeon globally to use the tricuspid device in the study. He says: “The past decade has seen an enormous expansion of research in, and subsequently—understanding of extracellular matrix. We have been using CorMatrix for eight 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 recognised 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 enrolment is a substantial step toward patients avoiding synthetic replacement valves by having the opportunity to regrow their own.”
The press release explains that the CorMatrix ECM tricuspid valve is a flexible, unstented valve constructed from the CorMatrix ECM material. It adds that 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 bioscaffold characteristics are designed to enable native cells to infiltrate and remodel over time into a fully functioning tricuspid valve. Therefore, the implanted, remodelled 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.