Human studies of the Pivot‑TR platform in patients with severe tricuspid regurgitation.
CCI 2026Pivot Bridge®
First-in-human
Safety and Efficacy of Pivot-Bridge for Severe Functional Tricuspid Regurgitation
Fifteen patients with severe functional TR were treated under fluoroscopy and TTE guidance. Procedural success was achieved in all patients, TR was reduced by at least one grade in every patient, and no serious adverse events occurred during implantation.
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EuroIntervention 2026Pivot Extend®
Case report
A novel spacer for transcatheter treatment of tricuspid regurgitation
Compassionate use in an 81-year-old patient with torrential functional TR for whom no commercially available device was suitable. The authors report roughly 50% TR reduction with the spacer self-centering during and after the procedure.
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KCJ 2024Pivot-Balloon
First-in-man
Safety and Efficacy of Pivot-Balloon for Severe Tricuspid Regurgitation
Pivot-Balloon, a preliminary form of the Pivot‑TR system, was used to evaluate spacer sizing for adequate TR reduction and to monitor acute hemodynamic change in patients with severe TR.
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