The discussion and conclusions presented in this document are based on the results of preclinical studies and are not intended to represent any approved or commercially available device(s).

Pediatric Bioprosthetic Heart Valve

Hancock Jaffe Laboratories intends to extend its line of adult heart valves and produce smaller diameter bioprosthetic heart valves to address the specific needs of the pediatric patient cohort undergoing valve replacement for congenital and/or acquired cardiac valve disease.

Hancock Jaffe Laboratories intends to extend its line of adult heart valves and produce smaller diameter bioprosthetic heart valves to address the specific needs of the pediatric patient cohort undergoing valve replacement for congenital and/or acquired cardiac valve disease.

The heart valve bioprosthesis incorporates the breakthrough technology developed by the Company as depicted and illustrated in United States Patent 7,815,677, “Intraparietal Aortic Valve Reinforcement Device and a Reinforced Biological Aortic Valve,” which eliminates the need for externally supporting structures to maintain valve geometry and function. Through a unique and elegant use of titanium wires embedded within the wall of the bioprosthetic valve, the traditional and typical requirement for an external support — technically referred to as a “stent” — is eliminated, which greatly increases the size of the bioprosthetic valve that can be placed in the patient’s annulus, the site of the inflow of the patient’s original valve. This could typically improve the effective functional result equal to a valve size two to three larger than could be possible to implant with an external stent. Additionally, the internalized titanium supports are robust enough so as not to require additional suturing – as is the case for weakly supported or stentless valves – allowing for the utilization of a single suture line for attachment of the valve.  Importantly, preclinical studies have demonstrated that the internalization of the supporting structures allows for an uninterrupted flow plane greatly increasing the volume of blood with each heartbeat.

Pediatric valve with a sewing flow designed for preclinical in vitro studies; three different sewing ring configurations have been designed for clinical procedures.
25mm Mitral Valve being prepared for preclinical study; the valve only requires a 60 second rinse.
Illustration showing the intramural stent. The design allows for stent discontinuity between the commissural and intercommissural attachments and the capacity to adjust the mural geometry mimetic of a native aortic root. Also illustrated are the locked support wires within the annular ring. An internal band (arrows) is pressed against the commissural supports during the crimping process; this assures the verticality of the commissures. The multiple holes in the annular ring allow for the proper positioning of valves with varying leaflet proportions; support wires and annular rings are fabricated from titanium. The radius of curvature at the apex of the commissural supports was specifically determined to circumvent the intramural attachment of the leaflets.

Potential Benefits of the Pediatric Bioprosthetic Heart Valve

…designed specifically for pediatric and adolescent patients;
…increased blood flow per heartbeat compared with other valves;
…enhanced flow may better accommodate patient growth and quality of life;
…reduce the likely number of procedures prior to receiving “adult” valve replacement.