Nitinotes Secures CE Mark for Automated Endoscopic Suturing Platform EndoZip

Israel-based Nitinotes Surgical has received CE mark approval for EndoZip, the first fully automated suturing platform for endoscopic sleeve gastroplasty (ESG), paving the way for its European launch. The system automates internal suturing used in ESG, a minimally invasive bariatric procedure that reduces stomach size without external incisions. Positioned as an alternative for patients unresponsive to GLP-1 receptor agonists (GLP-1RAs) but hesitant about traditional bariatric surgery, EndoZip aims to cut procedural times and simplify physician training by replacing manual suturing with automation.

Nitinotes plans an initial rollout in select European “centres of excellence,” followed by broader adoption supported by real-world data. The company also intends to initiate a pivotal IDE trial in the US to support future FDA approval. While GLP-1RAs continue to dominate obesity treatment, studies suggest ESG offers a cost-effective and durable alternative, maintaining long-term efficacy and potentially reducing patient weight regain after treatment cessation.

12-11-2025