Virtual Incision Completes IDE Clinical Study of MIRA

Virtual Incision Corporation has completed its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study, designed to evaluate the MIRA Surgical System for use in bowel resection procedures. 

The surgical cases were completed at three U.S. hospitals. Patients who participated in the study were followed after their procedure to fulfill study requirements. The complete data will be correlated and submitted to the FDA as part of the company’s De Novo request for market authorization. Virtual Incision is the first RAS developer to complete a U.S. IDE study to support a De Novo request in bowel resection.
 
“The investigators are very encouraged by our experiences trialing the MIRA Surgical System,” colorectal surgeon Michael A. Jobst, M.D., said. “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.”

MIRA is the world’s first miniaturized robotic-assisted surgery (RAS) system. Its small, sleek design is planned to offer the benefits of RAS during bowel resection procedures without the logistical inefficiencies of traditional mainframe robotics. The device weighs approximately two pounds and offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body. It can be used in any operating room—a dedicated mainframe room is unnecessary. With its drape- and dock-free design and portability, MIRA is quick to set up, clean up, and move between cases. Its conveniently accessible design positions it to be used as a standalone system or a complementary tool for facilities that already own a mainframe. 
 
Five million Americans undergo abdominal soft tissue procedures annually, however, more than 90% go without access to robotic-assisted surgery (RAS). If authorized by the FDA, MIRA’s miniaturized, strong, and easy-to-use design could potentially increase the overall availability of RAS. It has the potential to integrate into any facility or operating room by serving as a complement to the existing mainframe RAS systems, or by expanding into new sites of care and geographies as a standalone. Virtual Incision aims to increase patient access through a clinically, operationally, and economically sound platform available to all providers.
 
“Completing MIRA’s IDE clinical study is a critical milestone in our journey to making RAS more accessible,” Virtual Incision President/CEO John Murphy said. “Currently, less than 10% of the 90,000 operating rooms in the U.S. are equipped with mainframe RAS systems. Beyond the incredible progress of the industry pioneer, it’s still in the early days of the adoption of soft tissue surgical robotics. Our ultimate goal is to develop world-class miniature RAS devices with the required strength and dexterity to enable positive clinical outcomes for a broad range of procedure types.”
 
Virtual Incision is aiming to simplify robotic-assisted surgery so more patients and their surgeons can access its benefits. Headquartered in Lincoln, Neb., and holding more than 200 patents and patent applications, the company is developing MIRA, the first-of-its-kind miniature RAS platform. 

Read more: Global Surgical Robotics Market to Reach $10.3B by 2030