The new Medtronic Robot-Assisted Surgery system: Hugo RAS

 

Medtronic has just revealed its modular Robot-Assisted Surgery system. Earlier speculations suspected the name Einstein would be used. Medtronic licensed DLR's MIRO technology quite some time ago, and foresaw revenue form the RAMIS system already in FY18. The new Hugo RAS system is currently used in cadaver trials, and CE marking is projected for the second half of fiscal 2021.

Based on their Form 8-K, "The Investor Update included a RAS prostatectomy procedure performed in a cadaveric lab as part of the Medtronic Minimally Invasive Therapy Group’s ongoing development and testing process of its RAS technology, as well as a short procedure overview with pre-recorded video from a recent cadaveric procedure that was also part of the Company’s ongoing development and testing process. Medtronic’s RAS technology is currently under development. Participants should not infer indications for use. 

The system is not cleared or approved in any market and is not available for sale or clinical use. In addition, the update included remarks and responses to audience questions from a panel of surgeons and Medtronic management. 

The investigational system showned in the update includes a tower, surgeon console, surgical end effectors, and robotic arm carts. The objective of the tower design is to provide a solution that is 

1. universal (both RAS and laparoscopic applications), 
2. upgradeable,
3. modular. 

The surgeon console design aims to provide (1) an open architecture and (2) a three-dimensional, high-definition visualization. The surgical end effector design aims to (1) take advantage of the expertise, know-how, and IP of our existing MITG surgical instrumentation portfolio, and (2) use across a broad spectrum of surgical procedures. The robotic arm cart design aims to provide a solution that is (1) modular and portable, (2) allows for flexible positioning (use one or up to four arms), and (3) uses Medtronic end effectors.  Medtronic’s robotic-assisted surgical system is an investigational device currently under development. Safety and effectiveness of the system has not been established. The system is not cleared or approved in any market and is not available for sale or clinical use."

"During the investor update held today in Hartford, Conn., Medtronic EVP Bob White repeatedly claimed that only 2% of surgeries around the world are held with the assistance of robots.

“There’s 98% out there that needs to be done via robotically-assisted surgery but not today because of the cost and utilization burdens,” said White, who is president of the Medtronic’s Minimally Invasive Therapies Group.

Said CEO Omar Ishrak: “In 10 years, not only this robot but other robots we have going will change the face of surgery.”

Medtronic plans to launch the system in undisclosed places outside the U.S. early the next year, allowing the company to start gathering clinical data, White said. CE Mark and U.S. IDE submissions will follow later in the year, with a goal of achieving U.S. 510(k) clearance in about two years.

White said Medtronic won’t “give the robot away” to health providers, but he’d like to see the company drive procedure costs for the system down to levels seen with laparoscopic systems.

The system includes a tower, surgeon console, surgical end effectors, and robotic arm carts.

Key aspects of the system include:

• Modularity — The arms and other parts of the system are modular — and they’re on wheels — allowing for flexibility when it comes to placement and swapping around parts of the system. A surgeon could complete a procedure with an arm, push it out of the way, and start a laparoscopic procedure still using the tower, for example. After the surgery, hospital staff could undrape the system and roll it into a second sterilized and prepped OR so that the surgeon could quickly start a new surgery after a break. Because the arms are modular, a hospital could split up the arms for use in different procedures at the same time.
• Universal use — The tower and its visualization system, generator, processors and endoscope are meant to support both robot-assisted surgery and laparoscopic applications, and even open surgery. The endoscope, for example, is a standard length. The FT10 generator powering the robotic system is the same type of generator powering laparoscopic and open surgery devices.
• Upgradeable — Medtronic designed the system so that health providers can swap in new systems, generators, etc. as they become available, without having to buy an entirely new system. The company also has a pipeline of software applications and features that it will continually roll out.
• An open console — The surgical console design boasts an open architecture with foot pedals so that surgeons can still interact with the patient and OR staff during procedures. At the same time, three-dimensional, high-definition glasses provide an immersive situation.
• Drawing on existing surgical tool expertise — Medtronic is taking advantage of the expertise, know-how, and IP from its existing surgical instrumentation portfolio, which makes sense because the system’s instruments could be a big revenue source for the company. Doctors consulting for the company said today that they also like that the surgical tools are familiar."

 Source: Medtronic, Sec.gov, MassDevice