A Better Way to Make Heart Valves

Authors:

Hobey Tam, Naren Vyavahare

PI/Advisor:

Naren Vyavahare

Program:

Bioengineering (College of Engineering and Science)

Abstract:

Over 300,000 heart valve replacements are performed annually giving rise to a $1.25B heart valve market with 7% annual growth. In emerging markets such as China, India, and Brazil, this growth is 11 – 15%. The current market gold standard is animal tissue heart valves treated with glutaraldehyde, a fixative that allows for the animal tissue to be implanted into humans. Unfortunately, these heart valves fail within 10-15 years due to calcification and structural degradation. This poses a clinical need because we have young and middle aged patients needing heart valve replacements. The problem lies in the use of glutaraldehyde because it has been shown to predispose tissue to calcification and does not stabilize the entire structure of the tissue. Therefore, we have developed and provisionally patented a novel fixation technique that utilizes alternative chemistries to produce an implantable biomaterial that is resistant to calcification and structural degradation. We have confirmed these claims by lab bench testing and materials properties testing as well as a small animal study. We have also found that our new biomaterial may be more biocompatible than the current market gold standard. These added improvements in efficacy could hold the potential to substantially increase implant life.

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