Korean Surgical Robot Zamenix Completes Clinical Trials for Kidney Stone Removal
Loen Surgical, a company specializing in surgical robot platforms, announced on the 1st that its AI-based kidney stone surgical robot Zamenix has successfully completed clinical trials for robot-assisted flexible ureteroscopic stone removal, marking it as the first invasive innovative medical technology in South Korea.
Designated as the 17th innovative medical device in 2021, Zamenix is the world’s first AI-based kidney stone surgical robot. This device allows for the removal of stones by inserting a flexible endoscopic robot, measuring just 3mm in diameter, into the ureter without any incisions.
One of its key features is its respiratory compensation capability, which enables real-time tracking of moving stones to enhance laser accuracy. Additionally, the path replay function reduces surgery time, while the stone size measurement feature helps determine optimal crushing and removal methods, minimizing damage to the ureter and kidney. The remote control method also decreases radiation exposure for medical staff and reduces physical fatigue, thus enhancing procedural focus. To date, it has been implemented in 14 hospitals across South Korea and one internationally.
This achievement marks the first instance of a domestically developed surgical robot entering the regulatory framework based on high-quality clinical data. Despite the South Korean medical device industry having strong technical development capabilities, it has previously faced challenges in accumulating clinical evidence and linking it to regulatory processes. However, this case demonstrates the potential for success in these areas.
The clinical trials were conducted as a randomized controlled trial (RCT) comparing the safety and efficacy of Zamenix with the existing standard procedure, flexible ureteroscopy (RIRS). The results indicated that Zamenix achieved clinical outcomes comparable to traditional RIRS while confirming its advantages in operational precision and reproducibility specific to robotic platforms. Notably, even medical personnel with relatively less surgical experience observed high stone removal rates, suggesting that the robotic platform can help bridge the skill gap among surgeons.
The success of this clinical trial is seen as a foundation for expanding new treatment options for kidney stone management.
Designated as the 17th innovative medical device in 2021, Zamenix is the world’s first AI-based kidney stone surgical robot. This device allows for the removal of stones by inserting a flexible endoscopic robot, measuring just 3mm in diameter, into the ureter without any incisions.
One of its key features is its respiratory compensation capability, which enables real-time tracking of moving stones to enhance laser accuracy. Additionally, the path replay function reduces surgery time, while the stone size measurement feature helps determine optimal crushing and removal methods, minimizing damage to the ureter and kidney. The remote control method also decreases radiation exposure for medical staff and reduces physical fatigue, thus enhancing procedural focus. To date, it has been implemented in 14 hospitals across South Korea and one internationally.
This achievement marks the first instance of a domestically developed surgical robot entering the regulatory framework based on high-quality clinical data. Despite the South Korean medical device industry having strong technical development capabilities, it has previously faced challenges in accumulating clinical evidence and linking it to regulatory processes. However, this case demonstrates the potential for success in these areas.
The clinical trials were conducted as a randomized controlled trial (RCT) comparing the safety and efficacy of Zamenix with the existing standard procedure, flexible ureteroscopy (RIRS). The results indicated that Zamenix achieved clinical outcomes comparable to traditional RIRS while confirming its advantages in operational precision and reproducibility specific to robotic platforms. Notably, even medical personnel with relatively less surgical experience observed high stone removal rates, suggesting that the robotic platform can help bridge the skill gap among surgeons.
The success of this clinical trial is seen as a foundation for expanding new treatment options for kidney stone management.
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