FDA Grants De Novo Authorization for Virtual Incision Mira Surgical System

Virtual Incision Corporation announced in late February that the FDA authorized its miniaturized robotic-assisted surgery device, Mira Surgical System, under the agency’s De Novo premarket review pathway.

De novo classification eases the regulatory authorization pathway by classifying novel low- to moderate-risk medical devices for which there is no legally marketed predicate device. In this case, FDA classified Mira as a class II device indicated for the mobilization of the colon in adults at least 5’0” tall and 100 pounds or heavier who are undergoing minimally invasive colectomy procedures, according to a February 23 FDA letter to the Lincoln, Nebraska-based company.

Mira is the world’s first miniaturized robotic-assisted surgery (miniRAS) device, according to Virtual Incision press materials. The company had completed a 30-patient Investigational Device Exemption clinical study designed to evaluate MIRA’s use in bowel resection procedures, which led to the FDA nod.

While the results have not been released because the study is soon to be published in a peer-reviewed journal, study investigators were encouraged while testing the Mira Surgical System, according to a company press release.

“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,” said colorectal surgeon Michael A. Jobst, MD, in the release. “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.”

Something new

Mira is designed to eliminate the logistical inefficiencies of traditional mainframe robotics. The highly portable device sits on a cart and weighs about two pounds. It can be used in any operating room, whether the room has a dedicated mainframe or not.

“We took a different approach to surgical robotics, and really started from the drawing board,” Virtual Incision’s co-founder and chief technology officer Shane Farritor, PhD, MS, told MD+DI.

Farritor described existing robotic technologies as “big robots on the outside of the body that reach in from the outside,” which has some advantages but also limitations.

“Our approach was to make small robots that go on the inside,” he said. “That [approach] break a lot of assumptions about the world of surgical robotics and brings a lot of advantages to the table.”

Clinical advantages of the miniRAS device include multi-quadrant access, internal triangulation with shoulders and arms, and infinite wrist roll inside of the body. Practical advantages include short setup time, transportability between operating rooms and, in the future, the ability to use these devices in ambulatory care centers and other locations, Farritor said.

Mira is based on laparoscopic surgery, where surgeons make small incisions in the abdomen, then inflate the abdomen with gas to provide access to internal organs. The device is then inserted in that cavity through a specialized port. The arms and eyes of the camera of the device enter the body where it can directly access the surgical site, according to Farritor.

“We still have a user interface for the surgeon,” Farritor told MD+DI. “That’s the biggest component of our system. It has joysticks and a screen that allows surgeons to see what the robot sees inside the body. The device is totally controlled by the surgeon through the user interface.”

The robot and camera are handheld. The device’s light weight accommodates the surgeon’s actions when doing surgery in the small space of an abdomen, according to Farritor.

The goal to expand indications

Virtual Incision plans to pursue expanded indications in routine and high-volume procedures, many of which are one in outpatient and ambulatory surgery centers. Fueled in September 2023 by a $30 million extension to its previous $46 million Series C financing, the company has a gynecologic study on tap for this year. Additionally, it is developing a smaller iteration of the minibot to accommodate general surgery applications, including hernia and gallbladder surgery, according to Farritor.

The company envisions a new robot that uses the same camera and console but is more sensitive to incision size. “We’ll be making a device that will enter through a smaller incision,” according to Farritor. “Colon resection is not terribly sensitive to incision size because the specimen has to be removed after the procedure.”

Rolling out Mira

Virtual Incision is planning a controlled roll out of MIRA for the approved indication. “We want to enter a few hospitals and make sure we’re doing things properly and make sure things are going well, then we’ll expand from there,” he said, noting that part of the company’s FDA submission was to create a complete training program for device use.

“Just to give you an example, most surgical devices are draped to maintain sterility,” he said. “They’re generally covered with plastic. If you have a big robot, that’s a lot of plastic and time to cover up that whole thing. We made our device so it can be used right out of a tray, so it’s sterilized, as is, and can be picked up out of the tray and inserted into the body as a sterile device.”

Mira can complement existing robotic mainframes but the miniRAS is not meant to take the place of existing robotic technologies. “There are a lot of procedures that we think should be done with [existing RAS] devices,” Farritor said.

He said Mira could be more cost effective than existing RAS technologies because of its simplicity.