Edwards Lifesciences has received FDA approval for their invention TRIFORMIS RESILIA this week, it is the first surgical valve that is designed to specifically replace a diseased tricuspid valve of the human heart. Only 2.5% of patients out of 1.6 million ever receive a tricuspid valve replacement in their lifetime. Historically, innovative efforts to intervene a medical treatment for tricuspid valve have been avoided in favour of its associated risks.
The TRIFORMIS RESILIA tricuspid valve, model 11300T, is a stented tri-leaflet prosthetic heart valve comprised of RESILIA bovine percardial tissue. This low-profile valve is based on the Edwards PERIMOUNT valve designed with a nitinol wireform. The valve is mounted on a retainer with a holder system attached to the valve. The holder system has a dial that is turned prior to implantation to allow the posts to be folded inward during implantation.
Triformis is a surgical implant for patients with:
● Very large tricuspid annuli (the structural foundation for the tricuspid valve), often exceeding 55 mm, that fall outside the size range current transcatheter devices can accommodate;
● Concomitant open-heart surgery for left-sided disease who need a concurrent tricuspid intervention, and;
● Younger patients where the durability of a surgical valve outweighs the risks of the procedure.
More on the inner workings of the valve…
The lightweight wireform is made of a corrosion-resistant nickel-titanium
alloy (nitinol), chosen because of its superelastic characteristics, allowing
it to fold inward during implantation, and is covered with a polyester fabric.
A cobalt-chromium alloy band and polyester band surround the base of the valve below the wireform frame providing structural support for the orifice. Similar to other Edwards bioprosthetic valves, the nickel-titanium alloy wireform and cobalt-chromium alloy band in the model 11300T can be identified on fluoroscopy. This allows for identification of the valve’s inflow and outflow edges to facilitate identifying the landing zone for potential future transcatheter interventions. A compliant silicone-rubber sewing ring that is covered with a porous, seamless
polytetrafluoroethylene (PTFE) cloth is attached to the wireform frame and facilitates tissue ingrowth and encapsulation.
Sources & Credit;
The Company That Replaced Surgery is Selling Surgery: Edwards’ New Valve
https://www.linkedin.com/pulse/company-replaced-surgery-selling-edwards-new-4hpsc?utmsource=share&utmmedium=memberandroid&utmcampaign=sharevia
https://share.google/NBbl42v97IQATHvYO
P150048S092D.pdf https://share.google/I6tJx0V0WPlm302rz
Scriveners Online© 