Foldax Continues

[Kkch.i]

FYI, all heart valves are high risk Class III medical devices.

Got it thanks! I read in another post that you work in the valve industry. By any chance you know how I might find out the Foldax India trial size?

Bottom line: We will not know if the Foldax is superior to other valves or not for at least another decade or so...

That makes sense. I guess I should not overanalyze it and let time reveal the possibilities. It is hard but I will try

So I set that as a background and went about living life with my only goals being to develop myself and keep on learning.

That's a great attitude of living! I like your quote a lot - “We have two lives and the second begins when you realize you only have one.”

 

[Lucker]

I cant find the sample size of their India clinic trial. Wondering if that would be large scale.

The Indian testing group is definitely smaller than US (I remember that, though can't find the pricise number now), but that compensates with shorter term of the trial, after which everyone is welcome to the surgery, as I understand. India alone has 1,4 bn population, and count the medical tourists too.

 

[ATHENS1964]

https://www.dicardiology.com/conten...ated-tria-polymer-surgical-mitral-heart-valve

 

[pellicle]

https://www.dicardiology.com/conten...ated-tria-polymer-surgical-mitral-heart-valve

An Indian trial ... very interesting

 

[Humboldtgrrl]

https://www.dicardiology.com/conten...ated-tria-polymer-surgical-mitral-heart-valve

Thanks for this update on Foldax Mitral valve clinical trials in India. As the Indian clinicals report different specs (including shorter length) than the ones in USA, it seems that the Indian Foldax Mitral Clinical participants are "ahead of" the US Mitral participants. Despite no 10-20 yr results yet, things sound promising for Foldax valves that are surgically implanted. Much Gratitude to the Participants in all these Clinical Trials for their courage in venturing into the unknown.

 

[Aqua_Grim7]

Looks very promising! Wonder how long it’ll be before we’re seeing it in widespread use (assuming it continues to pass all its trials)…

 

[pellicle]

Looks very promising! Wonder how long it’ll be before we’re seeing it in widespread use (assuming it continues to pass all its trials)…

I'd say over ten years

 

[pekster11]

Foldax doing well in clinical trials it seems

 

[Protimenow]

'200 patient life years' is a fairly meaningless number unless (and I didn't listen to the audio, so I may have missed this step) you know HOW MANY were in the subject pool. If there were 200 patients in the research pool, living 1 year wouldn't mean much. If there were 50 in the pool, a 4 year survival rate would be more meaningful. This hasn't been in testing long enough for more than 5 or 6 years survival per patient (afaik), so it's not completely clear WHAT '200 patient life years' really means. I don't think you can extrapolate the results of 50 patients living 4 years each to suggest that the valve will, theoretically, last those implanted with the valve, for the rest of their lives (or, FWIW, 50 or more years).

 

[Springdogg]

There are 4 active studies underway according to clinicaltrials.gov.

https://clinicaltrials.gov/search?term=foldax

Both aortic and mitral valves with each having a study in the US along with one in India. I believe the earliest one was the US Aortic Valve which only started in 2019. According the max that's 175 patients across 4 studies. I agree this news does not showcase anything spectacular but its good to know that the studies are not encountering serious adverse issues postponing or ending them. I really hope for those needing replacements in the future an option like this is available to them. Pulling for these guys and anyone else pursuing advancement in valvular disease.

 

[pellicle]

If there were 200 patients in the research pool, living 1 year wouldn't mean much.

important point.

 

[Lucker]

Sure, longevity is essential, but let's not forget that the valve is pretty innovative, and even the basic things need to be tested, like basic structural integrity in vivo, abscence of allergic or immune reaction, and everything that science doesn't know about but what can happen.

 

[Chuck C]

The link below has some additional details:

“There are 120 active Tria patients we continue to follow in our clinical studies, encompassing over 200 patient life years,” said Ken Charhut, executive chairman of the board and CEO for Foldax. “Among them are early Tria valve patients with almost five years of experience and many more who have had the valve for over four years. These positive, durable results give us confidence to expand our clinical study to transcatheter aortic valves (TAVI). We are excited to continue gaining clinical knowledge and make our novel Tria valves available to more patients soon.”

https://cardiovascularnews.com/tria...ounced that its,on cardiac function over time.

 

[Protimenow]

Oops. Wrong thread

 

[Lucker]

Recent report for the mitral Foldax valve in India. They hope to finish the trial this year and have a regulator permission.