Edwards Lifesciences’ EVOQUE gained a CE mark in October this year to become the first transcatheter tricuspid replacement valve in the world to be approved.
This means it is also the first approved tricuspid or mitral valve replacement that can utilise a femoral transcatheter placement approach; the Tendyne from Abbott is the only approved mitral valve replacement, and it uses a transapical installation technique.
The initial success of transcatheter techniques for aortic and pulmonary valve replacements was something medical manufacturers looked to build on.
By 2014, five different mitral valve devices were being implanted as part of clinical studies.
The development of transcatheter mitral valves had begun before that of tricuspid valves, based on stronger clinical need and the existing surgical mitral valve market.
The challenging structure, access, and dynamics of the heart’s mitral valve presented significant challenges to the development of these devices, which must compete with the reliability of existing surgical valve replacements; as a result, this development process went through several iterations prior to the first approval.
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Common clinical guidance on tricuspid regurgitation (TR), where there is a backflow of blood through the valve at a point during each heartbeat, is to leave it untreated due to the risks of traditional surgery outweighing any potential benefit.
However, in recent years, studies have shown that the risks of untreated TR are higher than previously thought, and the favourable risk profile of transcatheter procedures led to a concentrated effort on the development of a device that could address TR.
Researchers found that little or no alterations were required for the mitral valve replacements such as the EVOQUE to be used for tricuspid replacement while the tricuspid valve’s easier access and less demanding anatomy than the mitral valve led to early studies showing very promising results.
With very few other treatment options available to patients experiencing TR, regulatory approvals have been accelerated.
The existing surgical market, which prompted a focus on the difficult mitral valve, now serves as a challenge to the mitral transcatheter devices while the lack of an existing market for tricuspid valves presents an urgent demand to manufacturers and promises improved care for TR patients.