Lungpacer Medical announced that it received FDA premarket approval for its flagship AeroPace neurostimulation system.
Lungpacer Medical 公司宣布其旗舰产品 AeroPace 神经刺激系统获得美国食品及药物管理局的上市前批准。
AeroPace uses neurostimulation via an electrode-containing cardiovascular catheter and a software-controlled system. It delivers periodic phrenic nerve stimulation through the venous catheter. The system contracts and strengthens the diaphragm in patients on mechanical ventilation.
AeroPace 通过含电极的心血管导管和软件控制系统进行神经刺激。它通过静脉导管提供周期性的膈神经刺激。该系统可收缩和加强机械通气患者的横膈膜。
Exton, Pennsylvania–based Lungpacer’s system received an FDA indication to improve weaning success. It aims to increase weaning, reduce ventilator days and reduce reintubation for patients aged 18 years or older on mechanical ventilation for 96 hours or longer without weaning.
总部位于宾夕法尼亚州埃克斯顿的 Lungpacer 系统获得了 FDA 的适应症，用于提高断奶成功率。该系统旨在提高 18 岁或 18 岁以上患者的断奶率，减少呼吸机天数，并减少未断奶机械通气 96 小时或更长时间的患者再次插管。
The company said in a news release that this marks the first FDA nod for a device of this kind.
该公司在一份新闻稿中说，这是 FDA 首次批准此类设备
Lungpacer says AeroPace offers “several clinical advantages compared to the current standard of care.” Clinical evaluations demonstrated more patients weaned, reducing the risk of remaining on mechanical ventilation at 30 days by up to 37%. Weaning speed came in nearly three days faster and the risk of reintubation at 30 days reduced by up to 60%.
Lungpacer 称，AeroPace “与目前的标准疗法相比具有多项临床优势”。临床评估显示，更多患者断奶，30 天后继续机械通气的风险降低了 37%。断奶速度快了近三天，30 天后再次插管的风险降低了 60%。
CEO Doug Evans says the FDA approval “represents a new era” for weaning patients off mechanical ventilation.
公司首席执行官道格-埃文斯（Doug Evans）说，FDA 的批准 “代表着 ”患者脱离机械通气的 “新时代”。
“We expect that the AeroPace System will improve the standard of care and transform the future care of mechanically ventilated patients by helping them recover durable independent breathing,” Evans said. “In memory of my son, Cameron, who endured the challenges of mechanical ventilation, we are all grateful to the dedicated physicians who conducted our three clinical trials and to the brave patients who participated in them such that their efforts will help many more patients to wean more quickly.”
“埃文斯说："我们希望 AeroPace 系统能够帮助机械通气患者恢复持久的自主呼吸，从而提高护理标准，改变未来对机械通气患者的护理方式。“为了纪念我的儿子卡梅隆（Cameron），他经受住了机械通气的挑战，我们都非常感谢开展我们三项临床试验的尽职尽责的医生和参与试验的勇敢的患者，他们的努力将帮助更多患者更快地康复。
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