FDA approves a new Biopolymer Heart Valve trial by Foldax

[jhusker2]

I came across this article the other day and the more I research the new technology behind the Biopolymer heart valve, the more intrigued I get! It's definitely worth following.... [h=1]Biopolymer Heart Valve by Foldax-[/h] https://www.apnews.com/bc0c2b46f3134dd2a05a830460a90014

 

[pellicle]

wow

... just 8 years too late for me ;-)

 

[Eva]

Interesting.

 

[ottagal]

That would be the Holy Grail....like the visual, Pellicle!

 

[ottagal]

Thanks for sharing this info, jhusker2. This is an excellent example of why I hope this forum continues. I always appreciate the wealth of information and knowledge shared here, in addition to the amazing support provided.

 

[tom in MO]

I always wonder how they get participants to try out new types of heart valves, when the existing ones work and a poor trial result could mean death. Anyone know what types of incentives they give or how they attract participants. For some things I know they offer it first to those who a standard valve replacement may not work.

 

[DDT77]

https://foldax.com/

https://foldax.com/wp-content/uploads/2019/02/YakubovTCT2017.pdf
appears fairly robust after ~ 7 years!

Something to watch with time on this topic:
https://clinicaltrials.gov/ct2/show/NCT03851068

associated granted US patents:
US9539089
US9301837

Wow!

 

[DDT77]

Seems like there will likely be a number of new options coming along:
https://www.researchgate.net/public...ement_Applications_In_Vitro_Hemodynamic_Study
https://medworm.com/673168361/swiss-heart-valve-dev-novostia-raises-7m/ --> https://www.novostia.com/preclinical-evidence

perhaps first light of the generation after:
https://medworm.com/672672154/scien...-that-are-essential-for-forming-heart-valves/ ?

 

[pellicle]

[
https://foldax.com/wp-content/uploads/2019/02/YakubovTCT2017.pdf
appears fairly robust after ~ 7 years!

and like manufacturing price ($25 per valve) ... double WOW

I see huge inroads into markets like India, Asia, Africa, ...
(I understand some people consider Inida part of Asia).

 

[ottagal]

This looks impressive! As Pellicle noted, $25 a valve versus $1000 for a bioprosthetic valve. This may be the game changer. Time will tell....

 

[ForeverThankful]

Thanks for posting this! Looks like it has a lot of potential, will be interesting to see where it goes.

 

[Warrick]

Can someone tell me how this becoming mainstream happens?
So as per the study if they implant the valve in 15 people and follow them for 5 yrs and there are no issues after this period it should recieve FDA approval?
So it could be daily use in say 6 yrs time? From what I have seen down my end of the world we jump on the FDA bandwagon pretty quick with new medical tech.

I’m assuming the FDA wouldnt give approval for a human trial without some pretty concrete results and performance already.

 

[honeybunny]

tom in MO, I was asked to participate in a research study on a new type of bovine AV (Edwards rapid deployment Infinity valve) a few days before my surgery. No incentives except for the fact that I would have testing each year at the study's expense. The study had been in place for two years already and results were looking good. Fast forward 3 1/2 years later, and I am dropping out because my tests are being billed to my insurance instead of paid by the study. This has been the case at 6 months, and at each year anniversary of my surgery. I am so disgusted at the ineptness of the research staff at Baylor-St. Lukes to pay ~$1000 for echos, the reading of same, and blood work while I receive past due notices from providers. I am now wondering if the research funding is deliberately being mishandled for nefarious purposes; i.e., someone at the hospital billing insurances and pocketing the money.

Other than these billing snafus, I have happily participated in this research.

 

[tom in MO]

tom in MO, I was asked to participate in a research study on a new type of bovine AV (Edwards rapid deployment Infinity valve) a few days before my surgery. No incentives except for the fact that I would have testing each year at the study's expense. The study had been in place for two years already and results were looking good. Fast forward 3 1/2 years later, and I am dropping out because my tests are being billed to my insurance instead of paid by the study. This has been the case at 6 months, and at each year anniversary of my surgery. I am so disgusted at the ineptness of the research staff at Baylor-St. Lukes to pay ~$1000 for echos, the reading of same, and blood work while I receive past due notices from providers. I am now wondering if the research funding is deliberately being mishandled for nefarious purposes; i.e., someone at the hospital billing insurances and pocketing the money.

Other than these billing snafus, I have happily participated in this research.

Thanks for the info.

 

[pellicle]

Hi

interesting information.

I'm curious if you don't mind:

tom in MO, I was asked to participate in a research study on a new type of bovine AV (Edwards rapid deployment Infinity valve) ... No incentives except for the fact that I would have testing each year at the study's expense

who asked you? Edwards or the hospital?

No incentives except for the fact that I would have testing each year at the study's expense.

did you keep that letter?

The study had been in place for two years already and results were looking good. Fast forward 3 1/2 years later,

so is this 3.5 years after it was in place or 5.5 years? I'm not sure if "had been in place" meant the study was pre-existing when you commenced or quite what.

and I am dropping out because my tests are being billed to my insurance instead of paid by the study.

and you received no notification communication of this?

This has been the case at 6 months, and at each year anniversary of my surgery.

but the study was operating yearly. I'm not sure if you are getting 6 month testing ... not that it matters as I don't really need to know..

I am so disgusted at the ineptness of the research staff at Baylor-St. Lukes to pay ~$1000 for echos, the reading of same, and blood work while I receive past due notices from providers

I'd be contacting your insurance company with this information and the participation in the study.

I am now wondering if the research funding is deliberately being mishandled for nefarious purposes; i.e., someone at the hospital billing insurances and pocketing the money.

entirely possible, I'd send the data on to the insurance company. It could be a genuine error on the part of the hospital. I know the administration in hospitals is huge and that tons of details are all over the place (aka disorganised) and as staff change "procedures" which were not well documented (and who reads that manual anyway) may slip off the proper processing horizon...

https://en.wikipedia.org/wiki/Hanlon's_razor

 

[Thomas]

Very cool. Hope I never need one.
thanks for the info

 

[honeybunny]

pellicle

Briefly (I'm at work)

I was asked by the research assistant, acting on behalf of my surgeon, though he is not the head of the study.
I don't recall receiving a copy of what I signed. Guess I had other things on my mind.
When I was asked to participate in September 2015, the study had been in place for two years or more, was my understanding. Thus, I did not feel I was taking a huge risk with a new valve.
I am getting past due statements from providers (though no threats of collection agencies). I have numerous email exchanges with the current research assistant who is trying to sort things out.
I have contacted my insurance company, all the providers, and Edwards Life Sciences.

The kicker is that the tech who did the first echo in October was not qualified to do that particular protocol and didn't get the pictures needed. I was asked to return a few weeks later for another echo. The first time I received $75 for travel and parking, the second time, nothing. And I have the same provider bills from the second echo, which was done because the first was incorrect.

I'll note that my research assistant has walked with me to Admissions to make sure my paperwork is correctly coded to the study account. I witnessed her standing over the shoulder of the patient intake CSR and discussing what codes needed to be entered to ensure I would not be personnally billed.

BTW, this hospital was in the news recently because of a high number of heart transplant deaths.
BTW2, I was not notified via email that I had been quoted here or I would have responded sooner.

 

[honeybunny]

Here is some info on the valve I received. The way I understood it, the rapid deployment technique is a bridge between traditional OHS and TAVR. It also meant less time on the heart/lung machine. My cardio told me I would have TAVR if replacement is needed in the future.

https://www.edwards.com/_layouts/Ed...icrosite/elite-microsite/rapid-deployment.htm

 

[pellicle]

Hi

thanks for the reply, I wasn't feeling that it was urgent (indeed I was more really just throwing ideas out for you as possibilities)

I don't recall receiving a copy of what I signed. Guess I had other things on my mind.

I was more thinking that they may have (should have) mailed something out to you confirming it ..

I am getting past due statements from providers (though no threats of collection agencies). I have numerous email exchanges with the current research assistant who is trying to sort things out.

well it "sounds" like they are doing the right thing and that its "cos we goofed" ...

I have contacted my insurance company, all the providers, and Edwards Life Sciences.

in writing I hope ;-)

BTW2, I was not notified via email that I had been quoted here or I would have responded sooner.

I guess you being a subscriber is why you get those, I only ever get them for personal message exists and @ mentions, not that I get them regularly

have you had a quick fish through your "spam" in case somehow their spam filtering system is stuffing that up?

I hope it gets sorted out soon.

Best Wishes