Nitinotes Expands EASE Trial to Orlando Health
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.
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 involvement marks a significant expansion for the multicenter trial, which aims to provide the necessary data for a future U.S. Food and Drug Administration marketing submission.
Lloyd Diamond, Chief Executive Officer of Nitinotes, noted that the system is designed to simplify and standardize the endoscopic sleeve gastroplasty process. By reducing technical complexity, the company hopes to make the procedure more reproducible for surgeons with varying levels of experience. While EndoZip currently holds a CE Mark for use in European markets, it remains restricted to investigational use within the United States until the trial reaches its conclusion.
Comments (0)
No comments yet. Be the first!