Real-world Safety and Performance of the Symani Surgical System® in Microsurgical Reconstructive Procedures: Primary Results from the PRIMO Study.
This non-randomized, multicenter post-market study of 412 patients (NCT04843436) evaluated the Symani Surgical System for microsurgical anastomosis in free-flap, nerve-repair, and lymphovenous procedures, with robotic-procedure technical success and procedure-associated complications as primary endpoints.
- Robotic-procedure technical success was 94.1% (507/539 anastomoses; 95% CI 91.7%–95.9%), and freedom from device-related events was 99.8%.
- First-attempt intraoperative patency was high, at 91.7% for free flaps (331/361) and 96.2% for lymphovenous anastomoses (225/234).
- Intraoperative revision was required in 8.4% of free-flap anastomoses versus 3.4% for lymphovenous and 0% for nerve repair.
- Free-flap survival at discharge was 97.8% (268/274; 95% CI 95.3%–99.2%).
The study was single-arm and non-randomized with no conventional-microsurgery comparator, and cases were enrolled both prospectively and retrospectively, so it cannot show whether robotic assistance improves on standard technique.