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Interview with Jason Beith: Creating the next generation valve, inventing Tria™ aortic and mitral surgical valve platforms

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15 June 2021


Dear Colleague,

Jason Beith PhD, Vice President of R&D at Foldax®, Inc., is a leader in the development of polymeric heart valves more durable than current tissue valves with no need for lifetime anticoagulation of mechanical valves. He is the inventor of the Tria™ aortic and mitral surgical valve platforms and led the development of the novel robotic manufacturing and production system.

Jason Beith PhD

Dr. Beith recently spoke with Rob Fraser, ViVitro Labs applications manager, about polymeric valves and advice to others trying to commercialize a radical idea.

You are making a flexible polymer surgical valve that also has transcatheter options. Please tell us how that work is progressing?

Jason Beith: We are making great progress. Our goal is to bring a suite of polymeric heart valves to the market that significantly improve upon current options. We’ve looked at different disease states and, in the west, the aortic is the biggest disease to address. We made the strategic decision to start with the aortic valve, prove the concept, and then move through to mitral and ultimately transcatheter aortic valve replacement (TAVR). I’m happy to say that we are the first polymer heart valve to be approved by the FDA for clinical investigation. We are currently conducting an Early Feasibility Study (EFS) that started out as a fifteen patients, but we have actually extended that to 40 patients based on FDA review of the initial results.

We currently have in excess of thirty patients walking around with an aortic valve and everybody is doing remarkably well. We have patients out over one year with no anticoagulation. The one year follow up and paper should be published relatively soon. On the heels of that, we’ve also been approved for an EFS for a mitral valve. We just recently had our first two implants in this study, so that is pretty exciting.

How has ViVitro helped with your work?

Jason Beith: We've had a long history with ViVitro going back now in my career more than 20 years. Going all the way back to David Walker. Most of us used pulse duplicators and your HiCycle testers. The pulse duplicator is something that we rely on, especially when you're in development of the heart valve. The only true feedback of how well a heart valve is working is from a pulse duplicator. You need a solid workhorse that is non-varying and that's definitely what you have with your pulse duplicator.


Read the full interview here.
 

Read other Cardiovascular Pioneer interviews here.

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On behalf of my team, I wish you and your family good health.

Sincerely,


Karim Mouneimne
President
ViVitro Labs Inc. /  ViVitro Labs SASU
kmouneimne@vivitrolabs.com


 

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