Homeskillet
Well-known member
Wow—soooo promising!
Foldax valve trials
- Thread starter Warrick
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Warrick
Well-known member
Latest updates on the Foldax valve if anyones interested
https://foldax.com/news/
https://foldax.com/news/
Warrick
Well-known member
And details of the valve material itself
https://foldax.com/wp-content/uploa...eveloped-for-Heart-Valve-Application-0218.pdf
https://foldax.com/wp-content/uploa...eveloped-for-Heart-Valve-Application-0218.pdf
ATHENS1964 - I'm not intending for this to be a pun, but I tried to read that morphology paper, and most of it was greek to me.
Will it be available for trans-catheter valve-in-valve implantation?
On Foldax - My understanding is (hey guys, please correct me if you have a different understanding)
Their goal is to provide a heart valve product that will last “a lifetime” (Younger folks will not have to face the difficult decision of mechanical or tissue)
It will also solve the problem of not requiring a lifetime of testing and warfarin.
(To me, if Foldax can actually accomplish this, that would be remarkable!)
So as I understand it, first they have to get enough of these new valves implanted and see how well they perform, etc. To that end, as of June, 2020, 3 patents have received the new valve, all (more or less) through standard surgery (or some through minimal evasive surgery). (But not yet through trans-catheter methods).
BUT clearly they state their intent is to provide a “percutaneously product" (their words).
To that end, they have already developed a transcatheter prototype product and successfully implanted it in animals.
So it would seem, only a matter of time!
As I approach 80 with my increasingly failing valves, I only hope I can hold out until they get that transcatheter product fully approved and ready for ME!
Their goal is to provide a heart valve product that will last “a lifetime” (Younger folks will not have to face the difficult decision of mechanical or tissue)
It will also solve the problem of not requiring a lifetime of testing and warfarin.
(To me, if Foldax can actually accomplish this, that would be remarkable!)
So as I understand it, first they have to get enough of these new valves implanted and see how well they perform, etc. To that end, as of June, 2020, 3 patents have received the new valve, all (more or less) through standard surgery (or some through minimal evasive surgery). (But not yet through trans-catheter methods).
BUT clearly they state their intent is to provide a “percutaneously product" (their words).
To that end, they have already developed a transcatheter prototype product and successfully implanted it in animals.
So it would seem, only a matter of time!
As I approach 80 with my increasingly failing valves, I only hope I can hold out until they get that transcatheter product fully approved and ready for ME!
Thanks for your comments, Jimmy! Let's hope for this to happen sooner rather than later!
it seems that Foldax is much further with their valve as they are already testing in vivo but today I saw this post on linked-in from the university of Cambridge on their PoliValve which is also a polymer one, thought you might find this an interesting read: New artificial heart valve could transform open-heart surgery
According to the paper, they predict that this valve will last 25 years. Thisis longer than most bioprosthetic valves (cow, pig, hippopotamus), but these are getting better.
The 25 year prediction, if accurate (and if this valve ever gets approved) is probably shorter than the actual life of the valve (perhaps it's wishful thinking), but many of us here have had mechanical valves in place for much longer than 25 years. Warfarin isn't that big a deal.
Perhaps, by the time this valve nears the end of its usefulness, other transcatheter replacements may become available. (One concern about failure of the valve - WHAT KIND OF FAILURE? - if leaflets weaken and break off, this can be catastrophic).
The 25 year prediction, if accurate (and if this valve ever gets approved) is probably shorter than the actual life of the valve (perhaps it's wishful thinking), but many of us here have had mechanical valves in place for much longer than 25 years. Warfarin isn't that big a deal.
Perhaps, by the time this valve nears the end of its usefulness, other transcatheter replacements may become available. (One concern about failure of the valve - WHAT KIND OF FAILURE? - if leaflets weaken and break off, this can be catastrophic).
Warrick
Well-known member
Damn scary " (One concern about failure of the valve - WHAT KIND OF FAILURE? - if leaflets weaken and break off, this can be catastrophic). "
I think ‘failure’ in the context of valves can be interpreted broader than just things breaking of. I would be surprised if mechanical strength hasn’t already been tested in vitro using test setups putting these new valves in overdrive. Failure by calcification or other forms of smaller but unwanted deformation of biological origin is what they are after now would be my guess
Of course it isn't just things breaking off. But for this type of mechanical, which emulates tissue (rather than a material that opens and shuts), I'm not sure if the types of failure have been fully explored -- they may not actually show up until years after the valve is implanted. Doing mechanical testing, putting these things into overdrive, may not be an accurate test -- issues may develop in valves that open and close between 50 and 150 times per minute that don't occur when the thing opens and closes many hundreds, or thousands, of times per minute.
nobog
Well-known member
issues may develop in valves that open and close between 50 and 150 times per minute that don't occur when the thing opens and closes many hundreds, or thousands, of times per minute.
Accelerated Life Testing is a relative test - you are correct there may be a difference between in-vivo and in-vitro scenarios and the industry takes that into account. The FDA requires tissue products to last 200 million cycles (5 years) and a mechanical-type valve to last 600 million cycles (15 years). This is really a minimum, the valves should last much longer than that. A "control" valve is always used when testing - a valve that has been on the market for many years with a known background. Tissue valves are very difficult to determine cycle life, the same design valve might go 200 million - or 2 billion cycles. Of course this test is really a bending under load test and does not simulate any body and or chemical reaction of the leaflets which leads to:
Failure by calcification or other forms of smaller but unwanted deformation of biological origin is what they are after now would be my guess.
Bingo !!
Accelerated Life Testing is a relative test - you are correct there may be a difference between in-vivo and in-vitro scenarios and the industry takes that into account. The FDA requires tissue products to last 200 million cycles (5 years) and a mechanical-type valve to last 600 million cycles (15 years). This is really a minimum, the valves should last much longer than that. A "control" valve is always used when testing - a valve that has been on the market for many years with a known background. Tissue valves are very difficult to determine cycle life, the same design valve might go 200 million - or 2 billion cycles. Of course this test is really a bending under load test and does not simulate any body and or chemical reaction of the leaflets which leads to:
Failure by calcification or other forms of smaller but unwanted deformation of biological origin is what they are after now would be my guess.
Bingo !!
Failure by calcification - then the way to avoid this to avoid more calcification i.e. low fat low sugar no saturated fat unprocessed heavy on the greens Esselstyn vegan diet, statins K2, etc etc
Warrick
Well-known member
I think I recall reading somewhere calcium deposits won’t form or adhere to the foldax biopolymer material, similar to calcium not adhering to pyrolitic carbon in a standard mechanical valve.
nobog
Well-known member
Do you have any evidence to support that?
https://www.heart-valve-surgery.com...ium-supplements-heart-valve-leaflets-disease/
As far as I know, there is no diet that will slow or eliminate valvular calcification. Some believe the mediterranean diet, fish oils and vitamins help but it is no clinically proven. In my case, as soon as my calcified BAV was replaced, my cardiologist no longer recommended the fish oil or vitamins but pushed the mediterranean diet.
https://www.dresselstyn.com/site/faq/best diet for the heart
Warrick
Well-known member
Its just looking better and better for Foldax
https://cardiovascularnews.com/study-backs-biopolymer-used-in-foldaxs-tria-valve/
“The first of the company’s products—an aortic surgical heart valve—is currently enrolling a US clinical study as a result of FDA approval of an expanded study last October. Its second device, a mitral surgical valve, was approved by the FDA for a US clinical study last month, with the first human case expected to take place within the next several weeks. The third valve product is a transcatheter aortic valve implant (TAVI), which is in the pre-clinical testing phase.”
https://cardiovascularnews.com/study-backs-biopolymer-used-in-foldaxs-tria-valve/
“The first of the company’s products—an aortic surgical heart valve—is currently enrolling a US clinical study as a result of FDA approval of an expanded study last October. Its second device, a mitral surgical valve, was approved by the FDA for a US clinical study last month, with the first human case expected to take place within the next several weeks. The third valve product is a transcatheter aortic valve implant (TAVI), which is in the pre-clinical testing phase.”
