Surgical Robotics Technology
Virtual Incision Corporation has announced the successful completion of the first surgery in a clinical study assessing the safety and efficacy of its miniaturized robotic-assisted surgery (miniRAS) device in benign hysterectomy procedures.
More than one million women in the U.S. alone undergo surgery for benign gynecologic conditions annually.1 A minimally invasive approach can shorten the hospital stay, reduce blood loss and decrease complication rates compared to open surgery. Robotic-assisted surgery (RAS) devices, like MIRA, could elevate the surgeon’s vision, precision, and control when operating through a small incision, ultimately enabling the techniques to be performed on a broader range of patients.2 However, about 90 percent of U.S. operating rooms (ORs) are still lacking access to RAS, most often due to complex logistics such as dedicated space, specially trained staff, long turnover times and a substantial cost for the equipment.3.
MIRA’s innovative tray-to-table design could offer healthcare facilities the advantages of RAS without requiring them to organize the OR around the device. The miniRAS device’s compact, approximately two-pound (less than one kg), framework is portable and designed to make any OR robot-ready within minutes.
The MIRA Surgical System Hysterectomy Study is an international prospective clinical study designed to evaluate device performance and safety of the MIRA Surgical System when used to robotically assist in benign hysterectomy procedures. Outcomes from this study are planned to support future U.S. and international regulatory submissions for benign gynecologic indications. This study is the second clinical study of MIRA. The first study, under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) protocol, supported the De Novo marketing authorization for MIRA in colectomy procedures that was announced in February 2024.
This first surgery was successfully completed at the Geneva University Hospitals by Jean Dubuisson, M.D., Ph.D., a gynecologic surgeon and the principal investigator for the MIRA Surgical System Hysterectomy Study.
“Completing the first hysterectomy with the MIRA Surgical System is an exciting milestone for our hospital and for the entire field of gynecology,” said Dr. 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.”
“At Virtual Incision, we are anchored in clinical excellence as our first priority,” said Piet Hinoul M.D., Ph.D., chief medical officer of Virtual Incision. “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 grateful to the Geneva University Hospital team for their contributions, as well as to the patients who are willing to participate in this important work. We are excited to reach this milestone as part of our mission to make every operating room robot-ready.
In parallel to conducting the MIRA Surgical System Hysterectomy Study, Virtual Incision is continuing to innovate in the field of miniaturized surgical robotics. New iterations are in design that will enable MIRA to be applied across specialties including general surgery, urology, and other soft tissue and solid organ surgery.
SOURCE: Virtual Incision Corporation
