Real-world Safety and Performance of the Symani Surgical System® in Microsurgical Reconstructive Procedures

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OBJECTIVE: To evaluate the real-world reliability, safety, and effectiveness of a novel platform for robotic microsurgery when used to assist with microsurgical anastomoses. SUMMARY BACKGROUND DATA: The physical demands associated with advanced supermicrosurgical techniques strain human limitations. The Symani Surgical System ® is a robotic platform designed to support these challenging procedures with extreme motion scaling, tremor reduction, and miniaturized, wristed instruments. METHODS: This was a non-randomized, multicenter, post-market clinical follow-up study (NCT04843436) evaluating use of Symani for microsurgical anastomosis in adults (age 18+) requiring free-flap (FF), nerve-repair, or lymphovenous anastomosis (LVA) procedures. Cases were enrolled both prospectively and retrospectively. The primary endpoints were robotic-procedure technical success and incidence of procedure-associated complications. Key secondary endpoints were subjective usability, intraoperative patency, and FF viability at discharge. RESULTS: Between May 2021 and February 2025, 412 patients at 10 sites underwent at least one microsurgical robotic anastomosis. The procedure technical success rate was 94.1% (507/539 robotic anastomoses; 95% CI: 91.7%-95.9%). Freedom from device-related events was 99.8%. Intraoperative patency at first attempt was 91.7% for FF (331/361, 95% CI: 88.3%-94.3%) and 96.2% (225/234, 95% CI: 92.8%-98.2%) for LVA. Intraoperative revision rates were 8.4% for FF (31/367, 95% CI: 5.8%-11.8%), 3.4% for LVA (8/234, 95% CI: 1.5%-6.6%), and 0% for nerve repair (95% CI: 0.0%-26.5%). FF survival at discharge was 97.8% (268/274, 95% CI: 95.3%-99.2%). CONCLUSIONS: The study results support the safety, reliability, and efficacy of Symani when used for robotic-assisted, microsurgical reconstructions.

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