The first benign hysterectomy has been successfully performed using a miniaturized robotic-assisted surgery device in a clinical trial evaluating its safety and efficacy, Virtual Incision Corporation has announced.1
Takeaways
- The first benign hysterectomy using the miniaturized MIRA Surgical System has been successfully performed, marking a significant milestone in robotic-assisted surgery.
- Minimally invasive surgeries, including those using robotic assistance, offer reduced hospital stays, decreased blood loss, and lower complication rates compared to open surgeries.
- Minimally invasive surgery with robotic assistance has been linked to reduced pain, fatigue, nausea, and other symptoms, showcasing the benefits of this method over traditional open surgery.
- The MIRA Surgical System's small form factor and ease of setup make it accessible for use in any operating room without the need for dedicated spaces or extensive training, addressing major barriers to the widespread adoption of robotic-assisted surgery.
- The MIRA Surgical System has received De Novo marketing authorization from the FDA for colectomy procedures, and its ongoing clinical trials for benign gynecologic indications aim to further establish its safety and efficacy.
Benign gynecologic conditions are treated surgically by over 1 million women in the United States per year. Advantages of a minimally invasive approach vs open surgery include a reduced hospital stay, decreased blood loss, and lower complication rates.
Minimally invasive surgery has also been linked to reduced scores for pain, fatigue, nausea, lack of appetite, vomiting, numbness or tingling, abdominal and back pain, bloating, constipation, difficulty concentrating, urinary symptoms, leg cramps, and indigestion vs open surgery, showcasing the benefits of this method.2
The MIRA Surgical System (MIRA) is a robotic-assisted surgery (RAS) device developed by Virtual Incision Corporation.1 RAS devices can improve the surgeon’s vision, precision, and control, which increases the range of patients that can be operated through a small incision.
RAS is still not present in approximately 90% of operating rooms (ORs) in the United States, with reasons behind this deficiency including the need for dedicated spaces, specially trained staff, long turnover times, and a high equipment cost. The advantages of RAS can be provided without restructuring the OR using MIRA’s tray-to-table design.1
MIRA was built with a small, sleek form factor to overcome the barriers preventing widespread use of traditional mainframe robotics. Weighing under 2 pounds, the device is easily accessible for use in any OR.
A dedicated mainframe room is not necessary when using MIRA. Additionally, it is quick to set up and clean up MIRA, allowing fast transition between cases. It can be used as a standalone system or as a complementary tool for facilities with a mainframe.1
MIRA is being evaluated in the MIRA Surgical System Hysterectomy Study, an international prospective clinical study. Both the performance and safety of the device when used for benign hysterectomies are being assessed. This will provide support for future regulatory submissions for benign gynecologic indications.
Before the MIRA Surgical System Hysterectomy Study, the MIRA Surgical System was evaluated in a study using an FDA Investigational Device Exemption protocol. This study supported the February 2024 De Novo marketing authorization for MIRA in colectomy procedures.1
Jean Dubuisson, MD, PhD, a gynecologic surgeon and the principal investigator for the MIRA Surgical System Hysterectomy Study, conducted the first successful surgery using the MIRA Surgical System at Geneva University Hospitals. Dubuisson described the achievement as, “an exciting milestone for our hospital and for the entire field of gynecology.”
“Robotic-assisted surgery is a valuable tool, but technology access is still a challenge due to cost, time and operating room space,” Dubuisson said. “Miniaturization has the potential to overcome these issues and enable more women to have a minimally invasive option for their surgery.”
Alongside evaluation of MIRA through the MIRA Surgical System Hysterectomy Study, Incision will continue to innovate in the field of miniaturized surgical robotics. This includes the development of new designs that will allow MIRA to be applied across specialties such as soft tissue and solid organ surgery, urology, and general surgery.1
Reference
- Virtual Incision announces successful completion of the first hysterectomy performed with the MIRA surgical system. Virtual Incision Corporation. July 30, 2024. Accessed July 30, 2024. https://www.businesswire.com/news/home/20240730963211/en
- Krewson C. Open vs minimally invasive hysterectomy outcomes with enhanced recovery after surgery. February 21, 2024. Accessed July 30, 2024. https://www.contemporaryobgyn.net/view/open-vs-minimally-invasive-hysterectomy-outcomes-with-enhanced-recovery-after-surgery
