First Ever Miniaturized Robotic-Assisted Surgery Device Approved for Colectomy Procedures

Minimally invasive surgery (MIS), known for smaller incisions and enhanced patient recovery, has evolved significantly with the advent of robotic-assisted surgery (RAS), offering unparalleled precision and control for complex surgeries. However, about 90% of U.S. operating rooms (ORs) still lack this technology, primarily due to logistical challenges like specialized space requirements, trained personnel, elaborate setup and turnover processes, and high costs. Now, the introduction of the first miniaturized robotic-assisted surgery (miniRAS) device could address these barriers, potentially benefiting millions of U.S. patients annually.

Virtual Incision Corporation (Lincoln, NE, USA) has received FDA marketing authorization for its MIRA Surgical System, the world's first miniRAS device for adult colectomy procedures. MIRA stands out for its tray-to-table design, eliminating the need for significant OR reconfiguration, a common limitation with traditional large-scale surgical robots. The device's lightweight, portable design, weighing less than one kilogram, streamlines OR setup, allowing any OR to become robot-ready within minutes. MIRA's sleek, small form is tailored for colectomy procedures, bypassing the logistical hurdles of conventional robotic systems.

MIRA's design enables internal triangulation and infinite wrist roll inside the body. Its drape-and-dock-free setup and portability ensure swift preparation, cleaning, and transfer between cases. This versatile design makes MIRA suitable as both a standalone system and a supplementary tool for facilities with existing large-scale robots. MIRA's ease of use ensures any OR can adopt RAS technology. The wider commercial release of MIRA, along with its expanded application scope including gynecology, general surgery, and urology, marks a significant step forward. Plans are underway for MIRA's utilization in gynecological surgeries in 2024, and a new version tailored for general surgery is in development, with a first human trial expected outside the U.S. later this year. This innovation positions MIRA as a pivotal tool in transforming RAS accessibility and efficiency across various surgical disciplines.

“Colectomy is one of the most complex multi-quadrant abdominal procedures with nearly 50% still being performed as open surgery. Data from our IDE clinical study demonstrated that MIRA can successfully be used to mobilize the colon in a minimally invasive way,” said Piet Hinoul M.D., Ph.D., chief medical officer of Virtual Incision. “Starting with a difficult multi-quadrant procedure like a colectomy presents an exciting opportunity for us to address a high unmet need before we expand into other indications.”