Study results will be used to support the first FDA De Novo request for market authorization of the MIRA Surgical System as Virtual Incision makes progress towards its mission to expand RAS access
Virtual Incision is the first RAS developer to complete a U.S. IDE study to support a De Novo request in bowel resection. (Credit: Piron Guillaume on Unsplash)
Virtual Incision Corporation, a medical device company spearheading the development of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced the completion of its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study. The study was designed to evaluate the company’s MIRA Surgical System for use in bowel resection procedures. This is an important achievement towards bringing new technologies to hospitals and their surgical robotics programs regardless of the site of care.
The surgical cases were completed at three hospitals across the country. 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,” 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.”
There are 5 million Americans who undergo abdominal soft tissue procedures annually, however, more than 90 percent go without access to 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,” said John Murphy, president and chief executive officer of Virtual Incision. “Currently, less than 10 percent 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.”
Source: Company Press Release