2021年4月26日

美國食品和藥物管理局(FDA)批準IpsiHand中風康複係統上市，IpsiHand是一種新設備，適用於18歲及以上的中風康複患者，以促進肌肉再教育，維持或增加活動範圍。來自Neurolutions公司的IpsiHand上肢康複係統(IpsiHand System)是一種腦機接口(BCI)設備，可以幫助上肢或手、手腕和手臂殘疾的中風患者康複。“每年有成千上萬的中風幸存者需要康複治療。今天的授權為某些正在接受中風康複的慢性中風患者提供了額外的治療選擇，以幫助他們再次活動手和手臂，並滿足了可能無法獲得家庭中風康複技術的患者未滿足的需求。——Christopher M. Loftus醫學博士，FDA中風後康複設備和放射健康設計中心神經和物理醫學設備辦公室代理主任雖然中風是一種腦部疾病，但它可以影響整個身體，有時會導致長期殘疾，如身體一側完全癱瘓(偏癱)或身體單側無力(偏癱)。中風幸存者可能連最簡單的日常活動都有問題，包括說話、走路、穿衣、吃飯和上廁所。中風後康複幫助人們克服中風損傷造成的殘疾。IpsiHand係統使用非侵入性腦電圖(EEG)電極，而不是植入電極或其他侵入性特征來記錄大腦活動。然後，腦電圖數據被無線傳輸到平板電腦上，用於分析預期的肌肉運動(預期的運動功能)，並將信號發送到無線電子手托，後者反過來移動患者的手。該設備旨在幫助中風患者提高抓握能力。 The device is prescription-only and may be used as part of rehabilitation therapy. Assessment Study The FDA assessed the safety and effectiveness of the IpsiHand System device through clinical data submitted by the company, including an unblinded study of 40 patients over a 12-week trial. All participants demonstrated motor function improvement with the device over the trial. Adverse events reported included minor fatigue and discomfort and temporary skin redness. The IpsiHand System device should not be used by patients with severe spasticity or rigid contractures in the wrist and/or fingers that would prevent the electronic hand brace from being properly fit or positioned for use or those with skull defects due to craniotomy or craniectomy. Breakthrough Device The IpsiHand System device was granted Breakthrough Device designation, which is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA reviewed the IpsiHand System device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device. The FDA granted marketing authorization of the Neurolutions IpsiHand Upper Extremity Rehabilitation System to Neurolutions Inc. [Source(s): US Food and Drug Administration, PR Newswire] Related Content: