The advance of transcatheter tricuspid replacement and repair technologies for the treatment of tricuspid regurgitation mark this segment as one of the most exciting areas within the cardiovascular medtech space, the incoming president and CEO of TRiCares tells Cardiovascular News.
Ahmed Elmouelhi is a veteran of the medtech industry with around 20 years of experience from organisations including AtriCure, Medtronic and AGA Medical (now a part of Abbott). He has recently joined TRiCares, the developer of the Topaz transfemoral tricuspid heart valve replacement system, to replace the retiring president and CEO Helmut Straubinger, who has left the business following eight years in the role.
The company is currently progressing the Topaz valve replacement system through first-in-man studies, with a view to future regulatory approvals in Europe and later the USA.
“This space in particular is really at the cusp of taking off and becoming standard of care for tricuspid patients, who for a long time were the forgotten valve patients,” Elmouelhi comments. “The fact that now there are options where valves can be placed minimally invasively is tremendous.”
The market for transcatheter tricuspid interventions has been buoyed by the news of recent US Food and Drug Administration (FDA) approvals for Edwards Lifesciences’ Evoque transcatheter valve replacement technology and latterly Abbott’s TriClip tricuspid repair system.
“There have been really great regulatory milestones in the tricuspid space, whether it is replacement or repair,” says Elmouelhi who is positive that these initial approvals will open the door for other contenders in the tricuspid arena. “That paves the way forward for everyone else who is coming into this space.”
Elmouelhi says that a strength of the Topaz device is that it has been designed specifically to fit tricuspid valve anatomy, unlike other technologies that have been retrofit from other applications.
“The tricuspid valve is very different to the mitral or the aortic valve—its proximity to the conduction mechanisms and the AV [atrioventricular] node in particular, the fact that it is very flaccid, and there is not a lot of real estate to put radial force up against are things that have been taken into the design,” he explains.
With technologies being brought to market encompassing either valve repair or replacement, Elmouelhi says there is likely to be a need for physicians to have robust options for either avenue, given the need for unmet need for the treatment of tricuspid regurgitation (TR).
“This is such a big need and there are different stages at which the patients present. Some are extremely sick, they are all not candidates for surgery at this point, and a reduction to a certain grade of TR is acceptable.
“Others [patients] are maybe at an earlier stage and they need a total reduction of TR. That can be one of the differentiators – amongst many – between repair and replacement. What has been shown already, is that replacement has a profound impact in terms of complete elimination of TR for these patients,” says Elmouelhi, adding that ultimately physicians will decide which patients should be eligible for a complete therapy or at which point an adjunct would be sufficient.
