指定 against 株式会社UT-Heart研究所
Action summary
- Company
- 株式会社UT-Heart研究所Japanese onlyOriginal: 株式会社UT-Heart研究所Corporate Number: 9010901033048
- 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
Approximately 30% of patients with severe heart failure who underwent cardiac resynchronization therapy (CRT) were reported to have ineffective outcomes, and diagnosing ineffective cases is difficult. The product has novelty and high significance in that it can assist in predicting the effectiveness of CRT. Clinical research (11 cases) reported that the prediction of improvement in cardiac pump function using the product showed a high correlation (correlation coefficient 0.94) with actual effects, indicating high potential efficacy.
Show original Japanese text
心臓再同期療法※を行った重症心不全患者の中で約30％が無効例と報告されており、無効例の診断は困難である。本品は心臓再同期療法の効果予測の判断を補助できる点に新規性があり、画期性が高い。臨床研究（11例）の結果から、本品を使用した心臓のポンプ機能の改善の効果予測は実際の効果と高い相関（相関係数0.94）を示したとの報告があり、高い有効性が期待できる。
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
- 株式会社UT-Heart研究所 Japanese only
- Japanese name
- 株式会社UT-Heart研究所
- Corporate Number
- 9010901033048
- Registered address
- 東京都世田谷区野沢３丁目２５番８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.