Title:

Elastin Fixation Method for Bioprostheses

Case # InfoEd # 273
Inventors: Dan Simionescu & Naren Vyavahare
Summary: Tissue-derived materials either as allografts or xenografts are used in many cardiovascular surgeries. For example, bioprosthetic heart valves (BHVs) are used frequently for the surgical replacement of diseased valves. For use as a heart valve replacement, porcine aortic valves or bovine pericardium are crosslinked with glutaraldehyde and mounted on a supporting stent. While BHVs have demonstrated excellent properties in vitro, BHVs fail within 5-8 years after in vivo implantation because of biological degeneration and mechanical deterioration. We have shown recently that currently used glutaraldehyde fixation does not fully stabilize elastin, an important biochemical component of BHVs. Currently there are no technologies developed for elastin stabilization. Research conducted at the Cardiovascular Implant Research Laboratory at Clemson University has led to the development of a new fixation method, which increases the stability of elastin and elastin-rich tissues against degrading enzymes. This procedure reduces the propensity of the new biomaterial towards biological degeneration. The end results offer the potential for developing a novel BHV with extended durability in the clinical setting.
Applications: The medical device market based on xenografts and allografts is about one billion dollars annually. For example, there are about 175,000 heart valve replacement surgeries performed yearly worldwide of which about 80,000 in the US alone. Moreover, a large number of corrective cardiovascular interventions (vascular patches, heart valve repair, closure of congenital ventricular septal defects) require a durable elastin-rich biomaterial for use in cardiovascular surgery. These tissue-derived biomaterials are expected to function without failure for 15-25 years. However, it is now understood from our research that elastin protein is not fixed with conventional glutaraldehyde fixative and therefore, elastic component of the tissue is prone to enzymatic degradation ultimately leading to the failure of the device. There are five major companies that manufacture bioprosthetic heart valves and surgical repair biomaterials. Currently there is no extensible flat tissue material on the market.
Patent Status: Patent application has been filed. Detailed information must be provided under a confidential disclosure agreement. Please download the confidential disclosure form and mail the completed form to:

Vincie Albritton, Associate Director
Clemson Research Park
Office of Technology Transfer
91 Technology Drive
A.M.R.L. Building, Room # 220
Anderson, SC 29625
PH:  864-656-5708
FAX: 864-656-0474
Email:  valbrit@clemson.edu

Licensing: Our interest is to identify interested industry parties to license the process and to collaborate with in its further development. 
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Vincie Albritton, Associate Director
Phone: (864) 656-5708
Fax: (864) 656-0474
email: valbrit@clemson.edu

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Janet Dillon, Project Administrator
Phone: (864) 656-4237
Fax: (864) 656-0474
email: gjanet@clemson.edu

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