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World’s First Miniaturized Robotic-Assisted Surgery Platform to Make OR Robot-Ready
A miniaturized robotic-assisted surgery (RAS) platform with its small, sleek design offers the benefits of RAS during abdominal procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs only two pounds and can be used in any operating room (OR).
The MIRA Platform from Virtual Incision Corporation (Lincoln, NE, USA) is the world’s first miniaturized RAS platform and does not require a dedicated mainframe room. With its drape- and dock- free design and portability, MIRA is quick to set up, clean up, and move in between cases, enabling an increased robotic-assisted surgery caseload. With MIRA, every OR is robot-ready.
MIRA’s unique design allows surgeons to obtain full multi-quadrant access without the need of docking and re-docking a large, cumbersome external platform. It is simply inserted through a single port and held in place with an adjustable stand that attaches to the OR table. Due to MIRA’s small footprint, staff and surgeons may be closer to the patient than ever before. The space-saving surgical system is designed to help more ORs perform more RAS cases by leveraging their existing infrastructure.
MIRA’s design, along with the camera, can be easily cleaned and sterilized between cases without the need for special equipment. This eliminates the expense and time associated with draping that is necessary for other RAS platforms available today. A compatible suite of single-use disposable instruments is available to ensure surgeons have the tools they need. The surgeon console allows the surgeon to have complete control of MIRA’s instrument arms and endoscopic vision of the anatomy in real-time. With the goal of reducing training time, MIRA’s hand controls and foot pedals are designed to be familiar to minimally invasive surgeons. The console is built to improve surgeon ergonomics, allowing them to sit upright without having to put their head in an isolating chamber or wear inflexible headwear that other systems require. This gives surgeons the opportunity to perform RAS with improved situational awareness of the OR.
The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplement to complete the final stage of the company’s clinical study analyzing the MIRA Platform in bowel resection procedures. The approval was supported by a favorable interim clinical study report on the safety profile of MIRA. The IDE supplement approval puts Virtual Incision on track to obtain the clinical evidence needed to bring innovation to the soft tissue surgical robotics industry. Results of the completed study will support MIRA’s upcoming FDA De Novo application for market authorization.
“Our clinical experience has been extremely positive so far,” said Dr. Michael Jobst at Bryan Medical Center, the first surgeon in the world to operate with the device. “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.”
“MIRA was created to address the limitations of traditional robotic-assisted mainframe machines. We miniaturized and simplified MIRA to make it more accessible, easy to use, and easy to adopt,” said John Murphy, president and chief executive officer of Virtual Incision. “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.”
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