Foldax valve trials

[vitdoc]

Don’t get me wrong I hope that the Foldax valve works great and for many many years without catastrophic valve failure and little coagulation issues.
But I read the Study backs biopolymer used in Foldax’s Tria valve | Cardiovascular News link and it was typical company hype. Stuff like ”molecular engineered” or made robotically are hype phrases to make the product sound special. l.e. chemistry was involved to generate the material.
We will need to wait years to find out if these preform or not and what the longevity will be and what issues may develop. Personally I wouldn’t have one of these put in my chest at this time.

 

[pellicle]

We will need to wait years to find out if these preform or not and what the longevity will be and what issues may develop.

perhaps decades, for even if passed it'll be more years before it unfolds if they're safe or not ... who knows what can happen. Microscopi fragments breaking off and lodging in brain or lungs ...

Personally I wouldn’t have one of these put in my chest at this time.

me neither (even if I was a candidate).

But we do need live testers, and I expect that those clamouring for a "go on the dance floor" will be among the first to join a "class action" if harm comes and some lawyer notices that approvals are rushed. Funny how "it happened to me" changes things.

 

[epstns]

I find the "radical" new valve prostheses a lot like the newest cancer treatments. Sometimes you just have to make a decision based upon the best information available because by the time the long-term studies are out either the patient has died or that treatment has become obsolete.

I "rashly" chose a cancer treatment that "only" had 10 years of study history. I'm now almost 5 years post-treatment with favorable results. Had I gone with the "gold standard" my quality of life would have been unfavorably impacted. I took the chance and I think I'm coming out ahead. With heart valves, though, the downside is potentially far more unfavorable, though.

 

[pellicle]

With heart valves, though, the downside is potentially far more unfavorable, though.

hard to be sure ... my friend picked a radical new treatment for his cancer. The down side there seems pretty bad too

 

[epstns]

I guess one might differentiate between "new" and "radical" treatments. My cancer treatment was considered "new" - having only 9-10 years of results history to evaluate. Some actually refused to consider the treatment as being "too new" for them. I took it, and for me, it has worked out well.

Lots of variables. . . limited brain to process. (At least, for me.)

 

[pellicle]

Lots of variables. . . limited brain to process.

which is pretty much why we run trials, get an oodle of people pouring over the results, give ourselves time to think and then slowly decide.

That's in my view the conservative process.

 

[Humboldtgrrl]

Looking at Foldax, along with other AV, as there is a local Clinical Trials opportunity. Have only found 2 recipients referenced online, tho one was listed as the 3rd implant done. (#1 with Beaumont in MI. #3 with Christ in OH). The Trial is now expanded from 15 to 40 recipients at 6 Hospitals. If anyone hears any additional news on how recipients are faring, would appreciate a Post. #1, a prev runner, is quoted as back up to a 5K in under a year & is now about 1.5 yrs post surgery. Only interested in performance outcomes type info, to help clarify Risk:Benefit, not any recipient names or something that may be confidential. TIA

 

[pellicle]

Under consideration, along with other AV. Have only found 2 recipients IDed online, tho one was listed as the 3rd implant done. (#1 with Beaumont in MI, now both MD & recipient are moved. #3 with Christ in OH). The EFS is now expanded from 15 to 40 recipients at 6 Hospitals. If anyone hears of #2 or if there were actually 15 recipients with the first EFS, please Post. Or if you hear any additional news on any recipients. #1, a prev runner, got back up to a 5K in under a year & is now about 1.5 yrs post surgery. Interested in info, not speculations, to help clarify Risk:Benefit. The decision is complex enough. TIA

Well this looks like English, but I can't understand it as it seems to be highly truncated SMS (text minimalisation) style writing with no punctuation or gramma.

anyway, Welcome aboard and a great first post

 

[Humboldtgrrl]

Well this looks like English, but I can't understand it as it seems to be highly truncated SMS (text minimalisation) style writing with no punctuation or gramma.

anyway, Welcome aboard and a great first post

 

[Humboldtgrrl]

Oh, like OzTrayLeeYa?

 

[pellicle]

Oh, like OzTrayLeeYa?

exactly, although were I'm from is of less significance than what I write for others to read.

So are you a member of human trials on that thing?

 

[Humboldtgrrl]

it's only 1 of several AV under consideration, thus the inquiry to this group for any additional information.

 

[pellicle]

it's only 1 of several AV under consideration, thus the inquiry to this group for any additional information.

so you're considering this valve?

I didn't think it was even available yet ... I am still lost what the other stuff meant, but none the less I don't think this valve is even passed human trials yet ... @Warrick ?

 

[Humboldtgrrl]

Foldax is available in Early Feasibility Study Clinical Trials, as stated in original Post. I am only interested in any additional Information that may be available at this blog, if there is any, which there may not be & that is fine too.

 

[pellicle]

as I stated in original Post. Again

well that was what I wanted a translation of ... because it wasn't in any language I could understand.

do you have a link to the trial?

Googled it ... Early Feasibility Study for the Foldax Tria Aortic Heart Valve - Full Text View - ClinicalTrials.gov

Estimated Study Completion Date :

December 2024

 

[Humboldtgrrl]

You seem like a friendly person. It sounds as though you do not have any additional information on the Foldax Clinical Trials, which is the reason for my inquiry on this forum. Try googling Foldax.com for your general interest on this unique valve.

 

[pellicle]

Try googling Foldax.com for your general interest.

thanks ... I already did and you may note my following of this thread and make the valid assumption that I read the first post. I believe you won't find any of our participants here with experience with a valve that is in an ongoing trial and for which I'm confident there'll be an NDA for.

Best Wishes

 

[Humboldtgrrl]

Your point about NDA is well taken. I have rewritten my original inquiry post to clarify that I am not interested in any confidential information, such as names.

 

[Warrick]

From what I can see with googling and stumbling around the web theres not much in the way of information on the trials progress, I do recall someone here mentioning there is also a UK variation of a polymeric valve material but I cant recall where it was at, so perhaps Foldax is keeping their cards close for now.

Interestingly I did come across this from 2004-
https://academic.oup.com/ejcts/article/25/6/946/381455Which as time would suggest by the fact I have a piece of pyrolitic carbon in my chest and not a urethane valve this valve material
didn’t get off the ground.
Its only a matter time before something does.

 

[pellicle]

Your point about NDA is well taken. I have rewritten my original inquiry post to clarify that I am not interested in any confidential information, such as names.

one member here has contacted me by email to discuss things "off this forum" because she was threatened by her insurance company ... so they follow these places for "anonymous" transgressions