FDA Go-Ahead for CorMatrix Tricuspid Heart Valve Study

Biomaterials specialist CorMatrix Cardiovascular Inc., has gained FDA’s approval of its Investigational Device Exemption (IDE) for an Early Feasibility Study of its CorMatrix® ECM® Tricuspid Heart Valve.

Background

Extracellular Matrix (ECM) has become something of a buzzword in medical implant circles in recent years as it gains a reputation for being an effective bioscaffold. It 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 is gradually replaced as the patient’s own cells reinforce and rebuild the diseased or damaged structure.

Tricuspid valve replacement is required in a relatively small population compared with other heart valves. As such there has hitherto been relatively little interest in coming up with a procedure-specific valve that meets the specific demands of the procedure. The use of conventional valves is sometimes the only option, but is clearly not ideal, leaving a need for a tricuspid replacement valve to improve clinical outcomes for these pediatric and adult patient populations. This is where CorMatrix’s ECM Tricuspid Valve steps in. It is a flexible, unstented valve constructed from a sheet of CorMatrix ECM material, which is specifically 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 unique 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.

Advantageously for its target population the CorMatrix® ECM® Tricuspid Heart 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.

The newly announced IDE trial will evaluate the proof of principle and initial clinical safety of the CorMatrix® ECM® Tricuspid Valve at 5 US centers. Up to 15 subjects will undergo tricuspid valve replacement (TVR) with the 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 (age < 21) and adult endocarditis patients.

Investigator comments

Dr. Joseph Dearani, Chair, Division of Cardiovascular Surgery at the Mayo Clinic in Rochester, MN and Principal Investigator for the study commented, “I am pleased to have been asked to participate in this ground breaking 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.”

Company comments

David Camp, CorMatrix® Cardiovascular Chief Executive Officer added, “Our Company continues to advance the potential benefits of a total heart valve replacement device using the CorMatrix® ECM®.  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.   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.”

Source: CorMatrix, Inc.

 

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