Real-world Safety and Performance of the Symani Surgical System® in Microsurgical Reconstructive Procedures: Primary Results from the PRIMO Study.

Abstract

To evaluate the real-world reliability, safety, and effectiveness of a novel platform for robotic microsurgery when used to assist with microsurgical anastomoses. 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. 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. 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%). The study results support the safety, reliability, and efficacy of Symani when used for robotic-assisted, microsurgical reconstructions.