The procedures were conducted by Dr. Andre F. Teixeira and Dr. Manoel Galvao Neto, both key figures at the Orlando Health Weight Loss and Bariatric Surgery Institute. Their work marks a significant step in the multicenter EASE trial, which aims to generate clinical data for a future marketing submission to the U.S. Food and Drug Administration. The EndoZip system is designed to standardize the technically demanding process of endoscopic suturing, potentially making the procedure more accessible to a wider range of surgeons.
Nitinotes Expands EASE Trial to Orlando Health for Obesity Procedure
Surgeons at Orlando Health have completed the first procedures using the EndoZip Automated Suturing System as part of a pivotal U.S. clinical trial. The study, known as EASE, evaluates the safety and efficacy of the device for performing Endoscopic Sleeve Gastroplasty, a minimally invasive treatment for obesity.
Lloyd Diamond, CEO of Nitinotes, noted that the inclusion of Orlando Health strengthens the trial by leveraging the expertise of specialists who bridge the gap between traditional bariatric surgery and endoscopic care. While the device already holds a CE Mark for use in Europe, it remains restricted to investigational use within the United States until the trial reaches its regulatory conclusions.
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