作为中风紧急治疗的VitalFlow®磁面神经刺激器的开发

E. Sacristán, M. Borsody, M. Groh
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引用次数: 0

摘要

磁刺激面神经可以扩张大脑动脉,增加脑血流量。2010年,我们开始对磁刺激器进行概念验证测试,将其作为中风的早期临床治疗。2014年,我们成立了Nervive, Inc.,开发一种商业临床设备,我们称之为VitalFlow刺激器,目前正在FDA监督下进行PMA批准的临床试验。VitalFlow的故事是将发现从实验台转移到市场的案例研究,以及监管和资金考虑如何影响研发过程。
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Development of the VitalFlow® magnetic facial nerve stimulator as an emergency treatment for stroke
Magnetic stimulation of the facial nerve has been shown to dilate cerebral arteries and increase cerebral blood flow. We began proof-of-concept testing of a magnetic stimulator as an early clinical treatment for stroke in 2010. In 2014 we founded Nervive, Inc., to develop a commercial clinical device we called the VitalFlow stimulator, which is currently undergoing clinical trials under FDA oversight for a PMA approval. The VitalFlow story is presented as a case study in moving discovery from bench to market, and how regulatory and funding considerations influence the R&D process.
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