CroíValve’s system has already demonstrated positive results from its first-in-human TANDEM I trial in Europe. Image credit: Shutterstock/ramcreations.

The US Food and Drug Administration (FDA) has granted CroíValve an investigational device exemption (IDE) for its tricuspid regurgitation (TR) system. The company has initiated an Early Feasibility Study to evaluate the implant.

Irish-American company CroíValve’s DUO tricuspid coaptation valve system works together with the native valve to restore valve function in patients with TR.

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The early feasibility study, TANDEM II (NCT05913908), will test the safety and performance of the device in patients with severe or greater symptomatic TR. According to the trial’s entry on ClinicalTrials.gov, 15 participants are estimated to enrol. The primary outcome of the multi-centre, prospective, non-randomised trial is the freedom from device or procedure related major adverse events at 30 days. This includes death, intervention, and heart problems, amongst others.

With the IDE, CroíValve joins a busy clinical landscape for TR – a heart condition that affects around 1.6 million people in the US.  In October 2023, Edwards Lifesciences’ EVOQUE gained a CE mark to become the first transcatheter tricuspid replacement valve in the world to be approved. Israel-based Trisol kicked off its valve replacement early feasibility study in August 2023.

Unlike some approaches that solely employ valve replacement, CroíValve combines repair to reduce regurgitation. The device is comprised coaptation valve and an anchor system.

Also in the TR space is Abbott’s TriClip system – the company reported positive late-breaking data from the TRILUMINATE Pivotal trial early last year.

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CroíValve’s system has already demonstrated positive results from its first-in-human TANDEM I trial in Europe.

CroíValve’ CEO Lucy O’Keeffe said: “This marks a significant step forward in our efforts to continue generating clinical evidence demonstrating the safety and effectiveness of DUO.”

Unlike mitral, aortic, and pulmonary valve devices, the tricuspid valve market is more novel. According to GlobalData, by 2033, the transcatheter pulmonary valve replacement device market is predicted to be $116m, whilst the mitral valve repair device market is estimated to reach $331m.

These pale in comparison to the size of the transcatheter aortic valve replacement which is forecast to grow to $18.8bn. GlobalData has no tricuspid market projection, but a large proportion of thecardiovascular device markets arerapidly expanding due to the increasing prevalence of heart disease.