What is it about?

This study was conducted to evaluate the performance and safety of the newly developed Laryngeal Pacemaker System (LP System) for the treatment of bilateral vocal fold paralysis (BVFP). STUDY DESIGN: Feasibility, first-in-human, single-arm, open-label, prospective, multicenter study with a group sequential design and a 6-month follow-up period. METHODS: Nine symptomatic BVFP subjects were implanted unilaterally with the LP System. Pre- and 6-month post implantation evaluations consisted of the 6-Minute Walk Test (6MWT), the Peak Expiratory and Inspiratory Flow (PEF and PIF) evaluation, the PEF meter analysis, the 36-Item Short Form Health Survey (SF-36), the Glasgow Benefit Inventory (GBI), the 12-Item Voice Handicap Index (VHI-12), and the Fiberoptic Endoscopic Evaluation of Swallowing. The safety profile of the LP System was continuously monitored. RESULTS: The LP System implantation was achieved in 8/9 cases. Seven of the nine subjects completed the study. Absolute PEF and PIF values improved significantly 6 months post implantation (P < .05). 6MWT results showed a non-statistically significant improvement (P = .09). The mental component of the SF-36 showed a significant improvement (P = .043), whereas the other SF-36 components, the GBI, and the VHI-12 results did not changed significantly. The LP System did not affect the voice and swallowing quality and maintained a reliable safety profile for the duration of the study. CONCLUSIONS: This feasibility study showed that the LP System has the potential to become an effective and safe treatment for BVFP subjects without compromising the patients' voice.

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Why is it important?

The LP System is the first attempt to develop a selective laryngeal stimulator associated with a minimally invasive surgical procedure. The LP System has the potential to become an effective and safe treatment for bilateral vocal cord paresis/palsy (BVFP, BVCP).


Writing this article was a great pleasure as it has co-authors with whom I have had long standing collaborations. This article also lead to a new perspective in treatment options for bilateral vocal fold paralysis.

Prof., M.D. Andreas H. Mueller
SRH Wald-Klinikum Gera

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This page is a summary of: Laryngeal pacing via an implantable stimulator for the rehabilitation of subjects suffering from bilateral vocal fold paralysis: A prospective first‐in‐human study, The Laryngoscope, November 2015, Wiley,
DOI: 10.1002/lary.25792.
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