Study initiated for first miniaturised robotic-assisted surgery platform
pharmafile | April 20, 2022 | News story | Research and Development |
Virtual Incision Corporation has announced the FDA approval of an Investigational Device Exemption (IDE) supplement to complete the final stage of its clinical study, analysing the world’s first miniaturised robotic-assisted surgery (RAS) platform.
The MIRA Platform is a first-of-its-kind platform for bowel resection procedures, offering the benefits of RAS, without the inefficiencies associated with traditional robotics. The MIRA Surgical Platform features a small, self-contained device, which is inserted though a single midline umbilical incision in the patient’s abdomen.
The technology is designed to enable complex, multi-quadrant abdominal surgeries, and utilises minimally invasive tools and techniques familiar to surgeons. The platform does not require a dedicated operating room, or specialised infrastructure.
Dr Michael Jobst, the first surgeon in the world to operate with the device, has commented: “Our clinical experience has been extremely positive so far. I was able to perform 100% of the dissection with MIRA in all of my cases. We have also been pleased with its accessibility and efficiency. I operated on eight patients in five different operating rooms, and that’s something that’s just not possible with mainframe RAS platforms. MIRA has the potential to bring the benefits of minimally invasive surgery to more patients, and that’s truly exciting.”
The first cases of the study were completed at Bryan Medical Centre in Lincoln, Nebraska.
“MIRA was created to address the limitations of traditional robotic-assisted mainframe machines. We miniaturised and simplified MIRA to make it more accessible, easy to use, and easy to adopt,” John Murphy, president and CEO of Virtual Incision, shared. “These are the features that will allow surgeons to treat more patients each day. It is encouraging to see MIRA demonstrating the potential to help surgeons perform simplified robotic procedures safely and precisely. Completing the final stage of our clinical study will be a key milestone along MIRA’s regulatory pathway, and we will continue to focus on clinical excellence to best support the innovation we provide to patients and surgeons.”
More than 400,000 colon resection procedures are performed in the US each year. Minimally invasive colectomies have been shown to reduce mortality, and help to reduce a patient’s healing time, pain, complications, and hospital readmissions.
Ana Ovey
