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Research: Evaluation of a new balloon for fetal endoscopic tracheal occlusion in the nonhuman primate model.

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Research: Evaluation of a new balloon for fetal endoscopic tracheal occlusion in the nonhuman primate model.

Prenat Diagn. 2019 Apr;39(5):403-408. doi: 10.1002/pd.5445. Epub 2019 Apr 15. https://www.ncbi.nlm.nih.gov/pubmed/30861154

Evaluation of a new balloon for fetal endoscopic tracheal occlusion in the nonhuman primate model.

Sananès N1,2Regnard P3Mottet N1Miry C1Fellmann L3Haelewyn L3Delaine M1Schneider A4Debry C2,5Favre R1.

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Abstract

OBJECTIVE:

We developed a new balloon called “Smart-TO,” which allows noninvasive and easy unplugging, thanks to a magnetic valve actuated by the magnetic fringe field of a magnetic resonance imaging (MRI) scanner. The objective of this feasibility study was to evaluate the operation of this new balloon in a nonhuman primate model.

METHODS:

Four pregnant rhesus monkeys underwent fetal endoscopic tracheal occlusion using the “Smart-TO” balloon. The pregnant monkeys were simply carried around the perimeter of an MRI scanner a few days later. Study outcomes were feasibility of fetal tracheal occlusion using the “Smart-TO” balloon, persistence of the balloon in the fetal trachea, and deflation of the balloon when subjected to the magnetic fringe field of an MRI.

RESULTS:

At the time of the unplug procedure, in all cases, the balloon was still in a correct position, and its shape did not change based on their ultrasound appearance. After bringing the pregnant monkeys into the fringe field of the MRI scanner, the balloon deflated in all cases.

CONCLUSION:

The balloon we developed allows noninvasive, easily triggered, and externally controlled reversal occlusion, based on the nonhuman primate model. Further tests evaluating occlusiveness and potential adverse effects are necessary.

© 2019 John Wiley & Sons, Ltd.PMID: 30861154 DOI: 10.1002/pd.5445

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