Lungpacer Medical announced that it received FDA premarket approval for its flagship AeroPace neurostimulation system.
Lungpacer Medical 公司宣布其旗艦產(chǎn)品 AeroPace 神經(jīng)刺激系統(tǒng)獲得美國食品及藥物管理局的上市前批準。
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 通過含電極的心血管導管和軟件控制系統(tǒng)進行神經(jīng)刺激。它通過靜脈導管提供周期性的膈神經(jīng)刺激。該系統(tǒng)可收縮和加強機械通氣患者的橫膈膜。
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.
總部位于賓夕法尼亞州埃克斯頓的 Lungpacer 系統(tǒng)獲得了 FDA 的適應癥，用于提高斷奶成功率。該系統(tǒng)旨在提高 18 歲或 18 歲以上患者的斷奶率，減少呼吸機天數(shù)，并減少未斷奶機械通氣 96 小時或更長時間的患者再次插管。
The company said in a news release that this marks the first FDA nod for a device of this kind.
該公司在一份新聞稿中說，這是 FDA 首次批準此類設備
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 稱，AeroPace “與目前的標準療法相比具有多項臨床優(yōu)勢”。臨床評估顯示，更多患者斷奶，30 天后繼續(xù)機械通氣的風險降低了 37%。斷奶速度快了近三天，30 天后再次插管的風險降低了 60%。
CEO Doug Evans says the FDA approval “represents a new era” for weaning patients off mechanical ventilation.
公司首席執(zhí)行官道格-埃文斯（Doug Evans）說，FDA 的批準 “代表著 ”患者脫離機械通氣的 “新時代”。
“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.”
“埃文斯說："我們希望 AeroPace 系統(tǒng)能夠幫助機械通氣患者恢復持久的自主呼吸，從而提高護理標準，改變未來對機械通氣患者的護理方式。“為了紀念我的兒子卡梅隆（Cameron），他經(jīng)受住了機械通氣的挑戰(zhàn)，我們都非常感謝開展我們?nèi)椗R床試驗的盡職盡責的醫(yī)生和參與試驗的勇敢的患者，他們的努力將幫助更多患者更快地康復。
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