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]

https://www.dicardiology.com/conten...l-trial-tria-biopolymer-surgical-aortic-valve

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.

 

[user 15848]

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-
https://www.sciencedirect.com/science/article/abs/pii/S0021915020301076
“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:
https://www.ahajournals.org/doi/10.1161/JAHA.120.018506

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​

 

[user 15848]

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

https://www.dicardiology.com/conten...-biopolymer-surgical-aortic-heart-valve-india

 

[pekster11]

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

https://www.dicardiology.com/conten...-biopolymer-surgical-aortic-heart-valve-india

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

 

[Lucker]

Foldax expects to start commercializing the surgical aortic valve in India next year.

 

[Humboldtgrrl]

(Setting aside the Marketing aspects) Sounds like they are still in Clinical Trials in US, but are allowed to concurrently start Clinicals in India. Hopefully that means that the US Clinicals are still looking good, tho it's not a LT track record yet. Thanks to all the courageous Clinical participants & hope this option continues to look positive.

 

[Jmprosser.lab]

Any updates on Foldax anywhere?

 

[Lucker]

Any updates on Foldax anywhere?

There are some on their Twitter. And since no clinical study has been cancelled yet, no news is good news. I guess they would report the cancellation.

 

[ATHENS1964]

https://www.dicardiology.com/content/foldax-appoints-gregory-d-casciaro-chief-executive-officer

 

[Aqua_Grim7]

What’s the earliest this valve could be ready for use in the general population? When do you think the trials will be over?

 

[pellicle]

What’s the earliest this valve could be ready for use in the general population? When do you think the trials will be over?

no less than 10 years IMO

 

[pellicle]

here's the thing I don't understand: why is there a focus on the new and unproven (called bleeding edge for a reason) when there are already good alternatives around with sufficient time in the market to have more than 20 years of accumulated evidence on how they last.

People seem to get excited that their valve lasted a year ... what the hell was your expectation then? If I knew I'd only get a year out of a valve I'd be despondent. Each time I've had OHS I've assumed that I'd get 20 (although when I was a ten year old I didn't think like that, but by the time I was a teenager going to yearly follow ups I sure did and was always wondering how long will it last. At OHS #2 I certainly wanted to get durability.

What makes this viewpoint even harder for me to grasp is the highly emotional posts about "how long will I live" or "has my absolute lifespan expectation been dropped by 2 years" (with expectations of 80 years being reasonable).

I just can't fit concept A (yippee ... I got a year) and concept B (I want an untested unproven technology because it looks cool) together.

I mean if you were build a house and were told by the builder it might fall down at 12 or 15 years but would be guaranteed to 10 you'd walk away from that deal immediately.

Yet the losses of that are not "everything" ... because if you die you lose not just your house, not just your job, you lose everything.



If the focus of a person is longevity then avoiding reoperation would be significant factor.
If avoiding ACT (<organHorrorChord>blood thinners</organHorrorChord>) is the significant factor then Homograft is an option which will buy someone under 50 a statistically likely 15 years ...
https://pubmed.ncbi.nlm.nih.gov/11380096/

For all cryopreserved valves, at 15 years, the freedom was​

* 47% (0-20-year-old patients at operation), ​

* 85% (21-40 years), ​

* 81% (41-60 years) and ​

* 94% (>60 years). ​

Root replacement versus subcoronary implantation reduced the technical causes for reoperation and re-replacement (p = 0.0098).​

But to bet on an unknown dark horse ... are you feeling lucky?