Hugo received CE mark approval last month. The company is gearing up to conduct its FDA investigational device exemption (IDE) clinical trials in the U.S., with more on its stateside efforts still to come, Medtronic’s surgical robotics business head Megan Rosengarten told MDO recently.
The launch that followed is currently in what Martha called a “limited-release phase” as the company focuses on optimizing user experience as it deals with supply chain and manufacturing issues.
“It’s definitely not a demand issue,” Martha said on the earnings call. “Demand remains high — higher than we can fill at this point.”
The company is carrying on with regulatory filings worldwide, working with on U.S. IDE trials; procedures are being conducted with Hugo, Martha said. Another executive noted on the call that complexities have come into play, and the company should have provided more cushion to expectations for Hugo.
While Medtronic isn’t quantifying projections for next year, the company expects a healthy ramp-up for Hugo, planning for its fiscal year 2023 to “be a strong year for the robot.”
“We’re focused on making sure the initial experiences with surgeons are really good,” Martha said. “That’s the reason for slower revenue this year, but we expect a really strong ramp next fiscal year.”