TRiCares has been granted an investigational device exemption (IDE) by the US Food and Drug Administration (FDA) to initiate a pivotal trial of its Topaz transcatheter tricuspid valve replacement (TTVR) system for tricuspid regurgitation (TR) treatment.
TR is a condition in which the tricuspid valve of the heart leaks, allowing blood to flow backwards into the right atrium with every heartbeat. Affecting approximately 1.5 million people in the US, with only a small number of patients eligible for surgical treatment, the condition represents a high unmet need.
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Key unmet needs for the condition, which forces the heart to work harder, often resulting in issues such as fatigue and shortness of breath, include limitations in diagnostic imaging, resulting in delayed treatment decisions and interventional steps being taken, as per research published in 2022.
With the IDE in hand, Tricares anticipates that its pivotal trial for Topaz will support a future regulatory clearance of the TTVR system with the FDA.
The company intends for the pivotal trial to build on clinical progress for Topaz made in an early US feasibility study (NCT06506942), which the company gained an FDA IDE for in 2024, alongside the ongoing TRICURE European pivotal study (NCT06581471) that is currently enrolling patients at sites across countries including France, Germany, and Canada.
In May 2025, Tricares shared first-in-human data demonstrating improvements in TR, either to complete elimination or to normal mild levels, in 20 patients implanted with Topaz.
Tricares CEO, Ahmed Elmouelhi said: “Receiving FDA approval for our US IDE pivotal trial marks a significant milestone for Tricares and, most importantly, for the many patients living with tricuspid regurgitation who urgently need improved treatment options.
“This approval allows us to approach our investigator sites and prepare for first patient enrolments, bringing us closer to realising our ambition of making Topaz the standard of care for patients across the US.”
Also at the pivotal trial stage for a TTVR treatment is VDYNE. The Minnesota-based company obtained an FDA IDE for its catheter-based TTVR system earlier this month.
GlobalData analysis reveals that the global TTVR market is growing at a CAGR of 28.5% and is projected to reach a valuation of around $3.7bn in 2035, up from $304.6m in 2025.
Edwards Lifesciences’ EVOQUE is presently the only TTVR system approved in the US, while Abbott’s TriClip System is approved for tricuspid valve repair rather than replacement. Each company’s system received FDA approval in 2024, while Abbott’s system secured a European CE mark in October 2023.
