Foldax Continues

[AZATADINE]

You'd have to hand it to anyone who is brave enough to volunteer for one at this stage. Brave thing to do, especially if someone is in the young side. Fair dues to them.

Could be revolutionary.

 

[Humboldtgrrl]

Foldax Gets Indian Approval to Start Clinical Trial of Tria Biopolymer Surgical Aortic Valve

December 13, 2021 - Foldax Inc. announced that the Drugs Controller General of India (DCGI), India’s regulatory body for medical devices, has approved initiation of a clinical trial of the Tria biopolymer surgical aortic heart valve. The Tria valve reimagines the heart valve by combining the...

www.dicardiology.com

Thanks for this update & Link (with other great articles, as well). My sister had an opportunity to be in their KS trials earlier & declined. Hope things continue to go well for the clinical participants. We owe a lot to trial participants

 

[AZATADINE]

Thought this was interesting too even if it's just a company press release.

 

[jlcsn2015]

This may be the path to the future of mech-valves-end, at least makes more sense to me than tissue valves that will be attacked by design by the human immune system no matter who says what, a foreing tissue is a foreign tissue; I wish it was no the case, i would have chosen tissue valve instead of OnX, but it is what it is; and for me what was important 7 years ago it was-is Not to have a second OPS due to Valve Failure; That is my perspective do not want to be right, and as per guinea pig offers.... Hmmm no thank you, i know what the South Africans did to get first heart transplant, it was not nice....

 

[AZATADINE]

Tissue valves don't get "attacked" by the immune system. Where did you get that idea? That's not true.

 

[Warrick]

This would suggest cardiovascular calcification is an immune response-

Innate and adaptive immunity in cardiovascular calcification

Despite the focus placed on cardiovascular research, the prevalence of vascular and valvular calcification is increasing and remains a leading contrib…

www.sciencedirect.com

“Cardiovascular calcification is regulated through an integrated combination of innate and adaptive immune responses”
“Immunomodulatory drugs possess the potential to target and treat calcification.”

 

[pellicle]

Tissue valves don't get "attacked" by the immune system. Where did you get that idea?

Perhaps here:

Degeneration of Bioprosthetic Heart Valves: Update 2020

Mechanisms underlying SVD are incompletely understood, and early concepts suggesting the purely degenerative nature of this process are now considered oversimplified. Recent studies implicate the host immune response as a major modality of SVD pathogenesis, manifested by a combination of processes phenocopying the long‐term transplant rejection, atherosclerosis, and calcification of native aortic valves​

 

[jlcsn2015]

Tissue valves don't get "attacked" by the immune system. Where did you get that idea? That's not true.

MAYO CLINIC ARCHIVES

 

[AZATADINE]

I stand corrected then

 

[ATHENS1964]

First Patients Outside of U.S. Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial

First Patients Outside of U.S. Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial

May 5, 2022 – Foldax, Inc. has announced that the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA biopolymer surgical aortic heart valve. The TRIA valve reimagines the heart valve by combining the company’s proprietary...

www.dicardiology.com

 

[pekster11]

First Patients Outside of U.S. Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial

First Patients Outside of U.S. Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial

May 5, 2022 – Foldax, Inc. has announced that the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIA biopolymer surgical aortic heart valve. The TRIA valve reimagines the heart valve by combining the company’s proprietary...

www.dicardiology.com

Looks promising
I'd imagine it won't be known for decades how well this copolymer valve holds up in the human body

 

[Humboldtgrrl]

Re US Clinicals for Foldax: First implant patient 9/17/19 at Beaumont in Michigan. This link lists the participating hospitals. Early Feasibility Study for the Foldax Tria Aortic Heart Valve - Full Text View - ClinicalTrials.gov