Title:

New Material and Fixation Method for Bioprostheses

Case # InfoEd # 270
Inventors: Dan Simionescu & Naren Vyavahare
Summary: Bioprosthetic heart valves (BHVs) are used frequently for the surgical replacement of diseased valves. Fur use as a heart valve replacement, two types of tissues are used, the porcine aortic valve and bovine pericardium. In both cases, tissues are crosslinked with glutaraldehyde and mounted on a supporting stent. While these models have demonstrated excellent properties in vitro, BHVs fail within 5-8 years after in vivo implantation because of mechanical deterioration and biological degeneration. It is believed that the lack of elasticity of these tissues renders them susceptible to mechanical wear. Moreover, glutaraldehyde fixation does not fully stabilize elastin, and important biochemical component of BHVs. Currently there is no elastic biomaterial on the market and 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 biomaterial with improved mechanical and biological properties. The anisotropic material is endowed with considerable strength, is stiff in one direction and elastic in the other direction, making it very suitable for use in manufacturing of BHVs and for other uses in replacement and reconstructive cardiovascular surgery. Its flat shape allows for the possibility of fashioning the material into any desirable shape, size and orientation of the elastic component, therefore setting the basis for manufacturing of novel BHV designs. Moreover, our research led to development of an improved chemical fixation procedure, which reduces the propensity of the new biomaterial towards biological degeneration. The end result offers the potential for developing a novel BHV with extended durability in the clinical setting.
Applications: 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 strong, but extensible biomaterial for use in cardiovascular surgery. 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. 
Contact:

For more information about this technology, please contact:

Vincie Albritton, Associate Director
Phone: (864) 656-5708
Fax: (864) 656-0474
email: valbrit@clemson.edu

or 

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

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