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Virtual Incision’s MIRA Completes FDA IDE Study

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The miniaturized robotic-assisted surgery study will be used to support the company’s FDA De Novo request for market authorization.

Virtual Incision Corporation, a medical device company developing a miniaturized robotic-assisted surgery (RAS) system, has completed its United States FDA Investigational Device Exemption (IDE) clinical study designed to evaluate the company’s MIRA Surgical System for use in bowel resection procedures.

MIRA — the world’s first miniaturized RAS system, according to Virtual Incision — has the potential to integrate into any facility or operating room as a completement to existing mainframe RAS systems or by standing alone. It has a small design and footprint which helps surgeons quickly obtain full multi-quadrant access to the bowel and work closer to the patient. The system can be set up in an operating room in minutes without needing to drape, dock, or move heavy equipment and can be moved from room-to-room easily. These features allow for less downtime between procedures and reduced turnover time. Additionally, the companion cart is a portable storage and staging unit that requires only two cables — one to activate the camera and one for MIRA. The console gives the surgeon control of the instrument arms and camera using hand controls and foot pedals while they sit in the upright position.

For the IDE study, the surgical cases were completed at three hospitals across the US. Post-procedure, patients were monitored to fulfill study requirements. Virtual Incision reported that the complete data will be correlated and submitted to FDA as part of its De Novo request for market authorization.

“The investigators are very encouraged by our experiences trialing the MIRA Surgical System,” said Michael A. Jobst, MD, colorectal surgeon. “Across the sites, we’ve seen MIRA efficiently integrate into existing RAS programs and witnessed how it is mobile enough for use in any operating room. Some sites have even completed multiple cases in a single day. We are eager to fulfill the clinical requirements of the study in hopes that MIRA can help expand RAS access to more patients in the future.”

TAGS: Technologies
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