Aortech trileaflet valve

[deckard]

For a few years now I have been following development of a new type of 100% artificial, trileaflet heart valve that is intended to last a lifetime, yet require no anti-coagulants. The valve uses a new co-polymer (silicone-polyurethane) called Elast-Eon, developed over many years by an Australian company called Aortech. I read that one grade of Elast-Eon has already been approved by FDA for use in pacemaker leads which St Jude Medical has an exclusive supply agreement for. Percardia and Abbot Laboratories (for stent manufacture) also have agreements with Aortech regarding medical devices using Elast-Eon. The most lucrative use of Elast-Eon will be for heart valves and breast implants. Elast-Eon breast implants are currently pending approval by FDA. Aortech is currently doing pre-clinical development of their trileaflet valve designs for use in surgical, percutaneous and interventional valve replacement. The designs have been granted patents by the European Patent Office. And a percutaneous valve was presented to positive response in March 2006 at the Transcatheter Symposium in Washington D.C.

 

[PJmomrunner]

Sounds promising. Thanks for the info.

 

[AlonnolA]

Thanks for the info deckard. Do you have any links you can post?

 

[tobagotwo]

This was posted about a few years ago. The valves they created with Elast-eon did not wind up being usable without anticoagulation. I'm not sure why this product is bubbling up regarding valves again.
http://www.valvereplacement.com/forums/showthread.php?p=87007#post87007post87007

A German company, Adiam, also went out on a limb regarding polyurethane valves and anticoagulation a couple of years ago. Theirs was/is also a trileaflet valve. The company survived and the valves are still made, but there is no mention of doing without antiucoagulation on their website: http://www.adiam.de/index_e.htm

To this point in time, all claims made concerning polyurethane products and no requirement for anticoagulation had to be retracted, as they proved to be simply incorrect. Interestingly, the use of silicon may be part of the problem. The On-X mechanical valve, which seems to be the carbon valve with the least need for anticoagulation at this time, points to their highest purity pyrolytic carbon as being a major part of the reason - because it has no silicon residue in the finished product.

Best wishes,

 

[deckard]

Aortech

Aortech

The reason this is bubbling up again is that Aortech has been working to develop a NEW version of the trileaflet valve that does not require anti-coagulants. They claim there was a design flaw in the one from a few years ago so it did not pass the initial approval process, and this was nearly the downfall of the company since their eggs seemed to all be in one heart valve basket. After that setback, it took years to get the financing to continue development and they seem to now have a wiser marketing strategy under new ownership. As I said, Elast-eon is already being used in pacemaker leads, so it is for real. But the big money is in Elast-eon breast implants since silicone is no longer approved for implants. If this meets FDA approval, Aortech should have plenty of dough to put the more complicated valve testing thru the approval process.

But even if this or any new artificial valve not requiring drugs was approved and available soon, I would not want to be one of the first to have one. I deal with new technology all the time and know it is MUCH better to wait for v2.0.

 

[tobagotwo]

The requirements for a heart valve are very different from thsose for pacemaker leads or breast implants. There are a number of plastics that are already used for pacemaker leads, and breast implants made from other products have been around for a long time. The main concern for valves is durability and the creation of clots in a moving bloodflow, which are not issues with the other uses elast-eon has been put to. I'm not trying to put it down: elast-eon is a polyurethane, and polyurethanes are a very useful family of plastics.

I just wanted to note that this technology that has not fulfilled its promises to this point, and there have been some indications that it was the material that was at fault, rather than the design. The news from Australia was big; the news from Germany with their polyurethane entry was big. Then the promises failed to materialize. This is not brand new technology, and there is some basis for skepticism.

I'm all for it, if they can get it to work. I'll need another valve in 15 years or so, and I'm game for whatever will do the deed.

Best wishes,