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

Overview

Journal Bioengineering (Basel)

Date 2023 Sep 28

PMID 37760118

Authors

Min-Ku Chon

Su-Jin Jung

Jae-Young Seo

Dong-Hoon Shin

Jun-Hui Park

Hyun-Sook Kim

Joo-Yong Hahn

Eun-Kyoung Kim

Seung-Whan Lee

Yong-Hyun Park

Sang-Hyun Lee

June-Hong Kim

Affiliations

Soon will be listed here.

Abstract

The Pivot Mandu is an innovative device featuring a leak-tight adjustable 3D balloon spacer, incorporating inner mesh support, an outer e-PTFE layer, and a compliant balloon in the middle layer with a specialized detachable system. To assess its feasibility, proof of concept was rigorously evaluated through bench testing and survival porcine animal experiments. The results demonstrated successful remote inflation of the balloon system, with the balloon spacer exhibiting sustained patent and functional integrity over an extended observation period of up to 6 months. A noteworthy feature of the newly designed 3D balloon spacer is its capability for easy size adjustment during procedures, enhancing its adaptability and practicality in clinical settings. This three-layered 3D balloon spacer, with its established long-term patency, exhibits highly encouraging outcomes that hold promise in overcoming the current limitations of spacer devices for heart valve diseases. Given the compelling results from preclinical investigations, the translation of the Pivot Mandu into human trials is strongly warranted.

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