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近日，F(xiàn)DA授權(quán)銷售Apollo內(nèi)窺鏡套筒胃成形術(shù)（ESG）和Revise系統(tǒng)，這是FDA授權(quán)的第一個(gè)用于內(nèi)窺鏡套筒胃成形術(shù)的系統(tǒng)，這是一種促進(jìn)減肥的微創(chuàng)程序。在這個(gè)手術(shù)過(guò)程中，縫合裝置和攝像機(jī)通過(guò)喉嚨（食道）進(jìn)入胃，并用于在胃內(nèi)放置永久縫線，以減少胃的體積。它適用于肥胖（BMI 30-50 kg/m2）的成年人，他們無(wú)法通過(guò)更保守的措施（如飲食和鍛煉）減肥或保持減肥。

FDA官網(wǎng)信息如下：

FDA授權(quán)以下此類醫(yī)療器械為II類：

Endoscopic suturing device for altering gastric anatomy for weight loss. An endoscopic suturing device for altering gastric anatomy for weight loss uses suturing to approximate gastric tissue to restrict the volume of the stomach for the intended purpose of weight loss.

此次De Novo授權(quán)的Apollo內(nèi)窺鏡套筒胃成形術(shù)（ESG）和Revise系統(tǒng)的預(yù)期用途如下：

The APOLLO ESG and ESG SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI 30 -50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures. 

The APOLLO REVISE and REVISE SX Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI 30 - 50 kg/m2 by enabling transoral outlet reduction as a revision to a previous bariatric procedure.