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国産で初めて製造販売承認を取得した全人工手関節医療機器ニュース

帝人ナカシマメディカルは、全人工手関節「DARTS人工手関節」を開発し、国産で初めて製造販売承認を取得した。掌側と腕側を完全に固定せず、前後に滑らかに動かせる。

» 2016年11月09日 15時00分 公開
[MONOist]

 帝人ナカシマメディカルは2016年10月26日、全人工手関節「DARTS人工手関節」を開発し、国産で初めて製造販売承認を取得したと発表した。

 DARTS人工手関節は、関節リウマチなどにより、高度に破壊され機能不全に陥った手首の関節と置き換えて、その機能を代替するためのものだ。北海道大学大学院医学研究科の三浪明男前教授らが開発した。掌側と腕側を完全に固定せず、前後に滑らかに動かせる。そのような全人工手関節としては、日本で初めて臨床使用が許可された。

 適切な使用のためには、必要な措置を講じることが承認条件とされている。手関節の機能不全について十分な知識・経験を有する医師が、適正使用指針(関連学会との協力により作成された指針)を順守する、講習の受講により同製品を用いた治療に関する技術を得るといったことが必要となる。

 関節リウマチなどによって手関節が機能不全に陥った場合、日本国内では、これまで臨床で使用可能な人工手関節がなかったため、手術をし髄内釘(骨の髄腔内に設置する金属製の固定材)などで固定する方法がとられてきた。この方法は手関節が全く動かなくなるなど、患者の生活の質が低下してしまうという課題を抱えていた。

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