Innovative Medical Device Development for Adductor Spasmodic Dysphonia

Abstract

Adductor spasmodic dysphonia is a rare voice disorder characterized by strained and strangled voice quality with intermittent phonatory breaks and adductory vocal fold spasms. Type 2 thyroplasty is an alternative treatment for spasmodic dysphonia, addressing hyperadduction by incising and lateralizing the thyroid cartilage. The most important points for successful type 2 thyroplasty is the stable maintenance of the gap in the incised thyroid cartilage using titanium bridges.To date, titanium bridges have not been utilized for type 2 thyroplasty in any institution overseas, and no large-scale trial was currently planned.The clinical trial reported here investigator-initiated clinical trial conducted with the goal of obtaining approval for use of titanium bridges in Japan.We were fortunate to have the device designated for priority review under the government of Japan's Sakigake system, which significantly reduces processing time.This presentation will introduce our Medical Device Development with the Sakigake system.