Apollo gains CE marking for new endoscopic indications, with the OverStitch system, including ESG
Apollo Endosurgery has gained CE marking for new endoscopic indications, with the OverStitch system, including endoscopic gastric sleeve (ESG). In addition to endoscopic sleeve gastroplasty, the new indications include defect closure, stent fixation and transoral outlet reduction.
The new certificates were issued by British Standards Institute and were received by the company on November 17, 2022. The certificates are valid for five years. As part of the transition to European Union Medical Device Regulation, the OverStitch system has a new, more specific, intended use statement in the Instructions For Use (IFU) in CE-Mark countries, reading as follows:
"The OverStitch Endoscopic Suture System is indicated for the endoscopic placement of anchor sutures. Anchor-sutures can be placed for defect closure (e.g., perforation, ESD/EMR, and fistula/leak), stent fixation to reduce migration rates in the upper GI tract, endoscopic sleeve gastroplasty and transoral outlet reduction."
Apollo's products are offered in over 75 countries today and include the OverStitch Endoscopic Suturing System, the OverStitch Sx Endoscopic Suturing System, the Orbera Intragastric Balloon System, the X-Tack Endoscopic HeliX Tacking System, as well as the Apollo ESG, Apollo ESG Sx, Apollo REVISET and Apollo REVISE Sx Systems.
The Apollo ESG and Apollo REVISE Systems are intended to facilitate weight loss in patients with obesity (BMI 30-50 kg/m2) and are the first and only devices to be authorised by the FDA for performance of ESG and transoral outlet reduction endoscopy (TORe), respectively.
In November 2022, Boston Scientific entered into a definitive agreement to acquire Apollo, for a cash price of $10 per share, reflecting an enterprise value of approximately US$615 million. Apollo is expected to generate net sales of approximately US$76 million in 2022, as a result of the expected growth in its endoscopic suturing system franchise. Boston Scientific expects to complete the transaction in the first half of 2023, subject to satisfaction of customary closing conditions.