新型生物电子医学疗法研发商SetPoint Medical向FDA提交神经免疫调节设备的上市前审批医药_健康_365医药针灸按摩医药_健康_365医药中医中药医药_健康

新型生物电子医学疗法研发商SetPoint Medical向FDA提交神经免疫调节设备的上市前审批-动脉网

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新型生物电子医学疗法研发商SetPoint Medical向FDA提交神经免疫调节设备的上市前审批 SetPoint Medical submits neuromod device to FDA MASSDEVICE 等信源发布 2024-12-10 13:39 

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SetPoint Medical announced today that it filed with the FDA for premarket approval (PMA) of its neuroimmune modulation device.

SetPoint Medical今天宣布，它已向FDA申请其神经免疫调节装置的上市前批准（PMA）。

The Valencia, California-based company develops the system as a potential first-of-its-kind treatment for moderate-to-severe rheumatoid arthritis (RA). Its target population are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs)..

这家总部位于加利福尼亚州巴伦西亚的公司开发了该系统，作为治疗中重度类风湿性关节炎（RA）的潜在首创。其目标人群是不完全反应者，或对生物或靶向合成疾病缓解抗风湿药物（DMARDs）不耐受。。

SetPoint designed its rechargeable neurostimulation device to electrically stimulate the vagus nerve once daily. It activates the innate anti-inflammatory and immune-restorative pathways.

SetPoint设计了可充电神经刺激装置，每天一次电刺激迷走神经。它激活先天性抗炎和免疫恢复途径。

The company says it could potentially treat autoimmune conditions without the immunosuppressive risks associated with pharmacological therapies. After placement during an outpatient procedure, the system automatically delivers therapy on a preset schedule to improve compliance.

该公司表示，它可能会治疗自身免疫性疾病，而不会产生与药物治疗相关的免疫抑制风险。在门诊手术期间放置后，系统会按照预设时间表自动提供治疗，以提高依从性。

SetPoint Medical already has FDA breakthrough device designation for its system. Earlier this year, the FDA accepted the technology into its Total Product Life Cycle Advisory Program (TAP) pilot.

SetPoint Medical已经为其系统指定了FDA突破性的设备。今年早些时候，FDA将该技术纳入其总产品生命周期咨询计划（TAP）试点。

The company used data from its RESET-RA study to support the FDA PMA submission.

该公司使用RESET-RA研究的数据来支持FDA PMA提交。

“We remain steadfast in our goal to address the unmet medical needs in RA treatment and look forward to continuing to work cooperatively with the FDA during the upcoming PMA review process,” said Alexis Dineen, VP of regulatory affairs for SetPoint Medical. “I am incredibly appreciative of all the SetPoint employees, RESET-RA study investigators and participants who have helped us get one step closer to offering this new treatment category to RA patients.”.

SetPoint medical监管事务副总裁亚历克西斯·迪宁（Alexis Dineen）表示：“我们仍然坚定地致力于解决RA治疗中未满足的医疗需求，并期待在即将到来的PMA审查过程中继续与FDA合作。”。“我非常感谢所有SetPoint员工、RESET-RA研究调查人员和参与者，他们帮助我们向RA患者提供这一新的治疗类别迈进了一步。”。

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