Roen Surgical Supplies AI Kidney Stone Surgery Robot to Samsung Medical Center

Surgical robot platform company Roen Surgical announced on Nov. 6 that it has supplied the world’s first artificial intelligence (AI)-based kidney stone surgery robot, Zamenix, to Samsung Medical Center.

The official introduction of Zamenix by the Department of Urology at Samsung Medical Center is the first among the top five hospitals in Korea. Following its introduction at Kyungpook National University Hospital and Yangsan Pusan National University Hospital, kidney stone surgeries using Zamenix are expected to be fully implemented in Seoul and the metropolitan area.

The AI-based fully robotic kidney stone surgery robot Zamenix consists of a pair of flexible endoscope robots and a master console device that operates it remotely. The 2.8mm flexible endoscope applied to Jamenix passes through the urethra and ureter without incision to repeatedly remove stones. During surgery, once the flexible endoscope robot is set up for the patient, a single doctor controls it from the master console, and the flexible endoscope robot enters the body to perform the surgery.

Zamenix’s precise and stable control technology and various AI functions increase the fragmentation and removal rate of stones compared to existing surgical methods. Zamenix’s respiratory compensation function compensates for the movement of stones due to the patient’s breathing, enabling precise laser irradiation and accurate stone fragmentation, thereby ensuring safer surgery and reducing laser time.

Zamenix is equipped with an AI function that can determine whether a stone can pass through the ureter. Large stones are fragmented by laser and removed without damaging the ureter, aiding in safe and effective surgery. The path regeneration function recognizes the route taken by the ureteroscope to the location of the stone, innovatively improving the repetitive stone removal process.

Zamenix can reduce medical staff fatigue and radiation exposure risks through the surgical process using close-range remote control and robotic arms.

This surgical robot conducted a pivotal clinical trial in 2022 on 46 patients with kidney stones measuring 0.5 to 3 cm requiring retrograde intrarenal surgery (RIRS). The clinical results confirmed an efficacy rate of 93.5% in stone removal and a mild complication rate of 6.5%. These clinical trial results were presented at the European Association of Urology in March last year and won the Best Video Paper Award.

Kwon Dong-soo, CEO of Roen Surgical, said, “We are deeply grateful for the first introduction of Zamenix at Samsung Medical Center, which provides the highest level of medical services in Korea,” adding, “We hope that Zamenix will contribute not only to alleviating the pain of kidney stone patients but also to improving the difficulty and safety of surgeries for medical staff.”

Zamenix was selected as the 17th innovative medical device by the Ministry of Food and Drug Safety in December 2021 and obtained manufacturing approval from the Ministry in October 2022. It was selected as an innovative medical technology by the National Evidence-based Healthcare Collaborating Agency (NECA) in August last year, allowing its use as non-reimbursed or selectively reimbursed for three years starting this year. From the second half of this year, clinical trials will be conducted on 232 patients at five institutions to register it as new medical technology. After the clinical research is completed in early 2025, it will be available for in-hospital use for medical purposes. Subsequently, reimbursement will be determined based on the clinical evidence over three years through the Health Insurance Review and Assessment Service’s new medical technology registration evaluation.