The Development of a Permanent Implantable Spacer with the Function of Size Adjustability for Customized Treatment of Regurgitant Heart Valve Disease

Min-Ku Chon et al.

Bioengineering · 2023

Summary

This study introduced Pivot Mandu, a three-layer balloon spacer whose size can be adjusted during the procedure and then sealed for long-term implantation. In bench tests and pig studies lasting up to six months, the balloon inflated remotely as intended and kept its shape and function.

Part of the research behind the Pivot‑TR® platform for tricuspid regurgitation.

Key results

layers: inner mesh, compliant balloon, outer e-PTFE

6months

longest animal follow-up

pigs studied

bench expansion tests

Background

Why this study

Filled spacers must stay leak-tight for years, and fixed-size spacers cannot be tuned to each patient. Pivot Mandu combines a nitinol mesh, a compliant balloon and an e-PTFE cover with a detachable filling system so the operator can set the size and then leave it sealed.

Methods

What was done

Bench tests checked balloon expansion and size adjustment.
Survival experiments in 16 pigs ran from 2 weeks to 6 months, with echocardiography and necropsy.
Animals received anticoagulation during the survival period.

Findings

What was found

The balloon was inflated remotely and its size could be adjusted easily during the procedure.
Implanted spacers stayed patent and functional for up to six months.

Interpretation

What it means

Authors’ conclusion

The adjustable, leak-tight 3D balloon spacer showed long-term patency in animals, and the authors recommend moving it into human trials.

Limitations

Pig anatomy differs from human, notably at the cavotricuspid isthmus
TR severity graded visually
Small animal numbers

Overview

Study at a glance

Type: Preclinical (bench and animal)
Device: Pivot Mandu adjustable 3D balloon spacer
Model: Swine
Follow-up: 2 weeks to 6 months

Summary written by Tau Medical from the published article. Results from bench, animal or computer studies may not predict outcomes in patients.

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