Device Dossier

Apollo ESG NXT System - Suture/needle passer, single-use

Device Dossier for Apollo ESG NXT System - Suture/needle passer, single-use (Suture/needle passer, single-use, Class IIb, sponsor Boston Scientific).…

Intended purpose

The Device is 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 between 30-50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures.

TGA Public Summary