The clinical study evaluates the safety and efficacy of MIRA, the company’s miniaturized robotic-assisted surgery (miniRAS) device. A minimally invasive robot could shorten hospital stays and reduce blood loss. It could also decrease complication rates compared to open surgery for benign hysterectomy, the company said in a news release.
Virtual Incision’s MIRA system features a small, self-contained surgical device. Inserted through a single midline umbilical incision in the patient’s abdomen, it allows for complex, multi-quadrant abdominal surgeries. The system also uses existing minimally invasive tools and techniques that are familiar to surgeons. Altogether, MIRA weighs about two pounds.
MIRA’s tray-to-table design could provide the advantages of robotic surgery without requiring them to organize the operating room around the device — a current challenge with surgical robots.
Virtual Incision said devices like MIRA could elevate the surgeon’s vision, precision and control when operating through a small incision. This could ultimately enable surgeons to perform certain techniques on a broader range of patients.
Dr. Jean Dubuisson, principal investigator for the study, completed the first surgery at the Geneva University Hospitals.
“Completing the first hysterectomy with [MIRA] is an exciting milestone for our hospital and for the entire field of gynecology,” said Dubuisson. “Robotic-assisted surgery is a valuable tool, but technology access is still a challenge due to cost, time and operating room space. Miniaturization has the potential to overcome these issues and enable more women to have a minimally invasive option for their surgery. We are pleased with the results so far and look forward to further assessing the device in the MIRA hysterectomy study.”
More about Virtual Incision’s surgical robot study
Virtual Incision’s study — an international prospective clinical study — looks at performance and safety with MIRA. The company plans to use outcomes to support future U.S. and international regulatory submissions for benign gynecologic indications.
This study marks the second clinical evaluation of MIRA. The first, a U.S. IDE study, supported FDA de novo authorization for MIRA in colectomy procedures garnered in February.
Virtual Incision also continues to innovate in parallel to its hysterectomy study. The company said it continues developing new iterations for new specialties. These include general surgery, urology and other soft tissue and solid organ surgery.
“At Virtual Incision, we are anchored in clinical excellence as our first priority,” said Dr. Piet Hinoul, Virtual Incision’s chief medical officer. “We are encouraged by the results of our clinical and preclinical work to date, and we believe that miniaturized robotic-assisted surgery will have broad applications across a wide variety of procedures. … We are excited to reach this milestone as part of our mission to make every operating room robot-ready.”
