指定 against 第一医科 株式会社
Action summary
- Company
- 第一医科 株式会社Japanese onlyOriginal: 第一医科株式会社Corporate Number: 1010001004353
- Governing law
- 薬事法薬事法
- Action type
- 指定指定
- Action date
- February 28, 2017
- Issuing authority
- Ministry of Health, Labour and Welfare厚生労働省
Violation
The device is novel and highly innovative in that it is implanted in the tracheal defect site to maintain the structure of the trachea and serve as a scaffold for mucosal reconstruction. Clinical research (12 cases) suggests high efficacy in all cases, with results indicating the preservation of morphological and functional tracheal functions. After domestic clinical trials, it is planned to apply for approval in Japan ahead of the rest of the world.
Show original Japanese text
気管欠損部位に留置し、気管の構造を保ち粘膜再建の足場となる点に新規性があり、画期性が高い。臨床研究（12例）により、全例で高い有効性を示唆する結果（形態的・機能的に気管としての機能を保っている。）との報告がある。国内での治験を経て、世界に先駆けて日本で承認申請予定。
Source
Original Ministry of Health, Labour and Welfare announcement (in Japanese)The original Japanese disclosure is the authoritative record.
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Language
日本語版を見る (Japanese)Company info
- English name
- 第一医科 株式会社 Japanese only
- Japanese name
- 第一医科 株式会社
- Corporate Number
- 1010001004353
- Registered address
- 東京都文京区本郷２丁目２７番１６号
About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.