MIRA is an investigational robot that will enable surgeons to perform minimally invasive surgeries in any hospital or surgery center, without the need for a dedicated space or for the infrastructure typically required for other “mainframe” robotic systems. Weighing only two pounds, the miniature single incision platform has full robotic capabilities, and can be moved from room to room.
Virtual Incision also announced it is filing for an Investigational Device Exemption (IDE) with the FDA. An IDE approval will allow the company to initiate a confirmatory clinical study of the MIRA Surgical Robotic Platform in support of regulatory pathway to approval. The study will evaluate the safety and efficacy of the MIRA platform for colon resection surgeries in patients at a number of US investigational sites.
Virtual Incision’s goal is to increase patients’ access to minimally invasive abdominal surgery and to maximize hospital efficiency in various settings at a price point significantly lower than currently available robotic systems.
The Benefits of Minimally Invasive Procedures
“We designed the MIRA Surgical Robotic Platform with the fundamental understanding that minimally invasive procedures offer tremendous benefits to patients. We believe our portable and affordable abdominal robot has the potential to bring these benefits to many more patients,” said John Murphy, president and CEO of Virtual Incision. “The planned IDE clinical study of MIRA is the critical next step for the company.”
According to Virtual Incision, colorectal and lower gastrointestinal procedures are among the fastest growing surgeries in the US, with more than 400,000 colon resection procedures performed each year. Today, the most standard approach for treating patients with severe conditions is via a colectomy, which is often an invasive open surgery that can involve a very large incision, a long hospital stay and several weeks of recovery. Open colectomies carry a high risk of surgical site infection and other complications that can negatively affect a patient’s quality of life. Minimally invasive colectomies have been demonstrated to offer important benefits, and the use of miniaturized robotic surgery can potentially make these benefits more broadly available.
“Demand for minimally invasive surgeries continues to increase, and we are enthusiastic about the promise of the MIRA platform to meet this demand, while also delivering unparalleled flexibility,” said Dmitry Oleynikov, M.D., Virtual Incision’s co-founder and chief medical officer. “We are focused on expanding access to minimally invasive robotic procedures and delivering this innovation to the many centers where a smaller, simpler and less costly solution is needed.”