CorMatrix Receives FDA Approval for Tricuspid Heart Valve Study

CorMatrix Cardiovascular Inc. has received U.S. Food and Drug Administration (FDA) approval of an investigational device exemption for the early feasibility study of its ECM Tricuspid Heart Valve. The trial will evaluate the proof of principle and initial clinical safety of the Tricuspid valve at five U.S. centers.

Up to 15 subjects will undergo tricuspid valve replacement (TVR) with the Tricuspid valve 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 (younger than 21) and adult endocarditis patients.

“I am pleased to have been asked to participate in this study as the principal investigator. I believe the CorMatrix ECM Tricuspid valve has the opportunity to transform the treatment of the increasingly recognized tricuspid disease when valve replacement is inevitable. This first study should demonstrate the safety and feasibility of the treatment, allowing us to progress into pivotal studies,” said Joseph A. Dearani, M.D., chairman of the Division of Cardiovascular Surgery at the Mayo Clinic in Rochester, Minn.

The CorMatrix ECM Tricuspid Valve is a flexible, unstented valve constructed from a sheet of CorMatrix extracellular matrix (ECM) material. The device specifically is designed to function immediately after implantation as a competent heart valve and to perform efficiently at the normal lower transvalvular pressure gradients experienced by the tricuspid valve. In addition, the ECM’s 3-D scaffold characteristics enable native cellular infiltration and allow it to remodel over time into a functional heart valve, comprised primarily of the patient’s own tissue, the company claims in a news release announcing FDA approval. The Tricuspid valve should not require the long-term anticoagulation therapy associated with the implant of mechanical valves and does not represent a permanent long-term “foreign body” as is the case with historical mechanical or bioprosthetic valve designs, CorMatrix executives said.

“The approval of the CorMatrix ECM Tricuspid Valve early feasibility study is a major milestone for CorMatrix. We are excited to be advancing the development of this application of the CorMatrix ECM Technology. We are also pleased with the productive interaction with FDA in the early feasibility study process, which is allowing us to bring this potentially life-saving treatment to patients,” said Andrew Green, CorMatrix’s executive vice president of Operations.

An estimated 60,000 patients undergo heart valve replacement procedures annually in the United States, and approximately 1,000 of these surgeries are performed to replace tricuspid valves. There currently is only one device approved in the United States for tricuspid valve replacement with indication for the correction of tricuspid atresia, a specific type of congenital heart disease occurring in a very small pediatric patient population. As a result of the limited availability of FDA-approved products to replace the tricuspid valve, non-indicated devices often are used to replace irreparable tricuspid valves in adult patients; and pediatric patients are left with limited, low potential, or no surgical repair options. Subsequently, there is a need for a tricuspid replacement valve to improve clinical outcomes for these pediatric and adult patient populations.

“This product enables the patient’s own cells to replace the valve and gives us the opportunity to create additional options for patients needing tricuspid valve replacements. The approval of this IDE is a testament to the clinical potential of ECM and ECM device technology,” CorMatrix CEO David Camp said. “This accomplishment is particularly significant for pediatric patients where the valve has the potential to grow with the patient and reduce the number of future surgeries.”

Extracellular matrix material serves as a bioscaffold to allow vascular ingrowth from adjacent tissues to deliver progenitor cells and nutrients to the matrix, which then differentiate into tissue-specific cells and structures. The ECM material gradually is replaced as the patient’s own cells reinforce and rebuild the diseased or damaged structure. During repair, the matrix is naturally degraded and resorbed, leaving remodeled functional tissue where damaged or injured tissue would normally be expected. The safety of extracellular matrices has been well established in a number of different clinical applications and more than 500 published papers. Since 1999, an estimated 2 million patients worldwide have received an extracellular matrix implant.

Based in Roswell, Ga., CorMatrix Cardiovascular develops biomaterial devices designed to harness the body’s ability to repair damaged cardiac and vascular tissues. CorMatrix ECM Technology allows surgeons to restore the native anatomy of cardiac and vascular tissue in need of repair, serving as an alternative to synthetic or cross-linked materials. Since its launch in 2006, CorMatrix ECM technology has been used at more than 825 hospitals across the United States and has been implanted in more than 100,000 cardiac procedures, according to executives.