Bioprosthetic Heart Valves that Resist Structural Degradation and Stiffening (2013-055)

Market Overview:

This treatment stabilizes the connective tissue present in bioprosthetic heart valves to create durable and long-lasting replacement heart valves. There are approximately 300,000 heart valve transplantations performed globally each year and heart valve disorders are diagnosed in approximately four million people. There are major problems with the two heart valve replacement solutions currently available to patients: mechanical and bioprosthetic.  Mechanical valves require patients to take lifelong anticoagulants, generally making bioprosthetic valves the preferred approach. Glutaraldhedye is commonly used in bioprosthetic valves to stabilize one component of the connective tissue while the remaining components are not stabilized, causing the valve to lose its native behavior, structurally degrade, and calcify.  Clemson University Researchers have developed a treatment which stabilizes all components of the connective tissue in bioprosthetic valves, making the heart valve replacement more durability and resistant to degradation, stiffening, and calcification.

Application                                                                      Stage of Development

Cardiovascular surgery; heart valve replacement            In vitro and in vivo studies completed


•       Utilizes crosslinking chemistry to stabilize connective tissue, improving tear resistance and biocompatibility

•       Demonstrates significant reducing of calcification in tissue, helping the heart valve to resist structural       


Technical Summary

The treatment involves stabilizing the soft connective tissue – glycosaminoglycans (GAGs), elastin, and collagen – resulting in a bioprosthetic heart valve with a structurally stable extracellular matrix. This is done by crosslinking neomycin trisulfate, carbodiimide, and pentagalloyl glucose (NCPC) which allows for the penetration and manipulation of the tissue. In vivo studies have demonstrated stabilization and resistance to calcification. The stabilized connective tissue can also exhibit GAG retention over time.

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Inventors:                        Naren Vyavahare, Hobey Tam

Application Type:           Non-provisional

Serial Number:               61/881,611, 14/495,067

CURF Reference:           2013-055

Patent Information:
Biomedical Sciences
For Information, Contact:
Chris Gesswein
Director of Licensing
Clemson University Research Foundation
Narendra Vyavahare
Hobey Tam
Biomaterials - Cardiovascular
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