- Medtronic received CE mark for its Hugo robotic-assisted surgery system in Europe, moving the company closer to rival and market leader Intuitive Surgical.
- Hugo gained CE approvals for gynecological and urological procedures, which Medtronic contends make up roughly half of all robotic procedures currently performed, according to the Monday announcement. Rob ten Hoedt, president of Medtronic's Europe, Middle East and Africa region, said in the release the company has had "strong interest from leading surgical centers across Europe and expect[s] to move quickly with multiple installations in several countries."
- The Hugo system is an investigational device in the U.S. and not for sale. Evercore ISI analysts projected the FDA is likely to make a decision for approval in the second half of 2022.
Medtronic first unveiled Hugo two years ago as a challenger to Intuitive's leading da Vinci soft tissue robotic system. Hugo's timeline was delayed last year when the pandemic forced people to work remotely and the company could not get physicians to participate in lab testing.
Medtronic didn't file for a CE mark or an investigational device exemption until late March.
Despite a lot of hype for robotic surgery, including for orthopaedic systems from Stryker, Zimmer Biomet and Johnson and Johnson, a small percentage of surgeries are actually performed using the technology. Only about 3% of procedures are performed robotically, according to Medtronic.
The medtech giant contends that cost has played a role in limiting adoption. Some systems can cost upwards of $1 million, and hospitals will take on systems through a lease rather than buying them outright.
Medtronic said Hugo was developed to "address the historic cost and utilization barriers that have stifled robotic surgery adoption for two decades." Still, the medtech giant did not offer pricing information or comparisons in the release.
Hugo will be released as soft tissue procedures have been limited due to the shutdown of non-emergency care throughout the pandemic. Intuitive grew procedures by just 1% to 1.25 million in 2020, according to a January earnings call. By contrast, procedures grew by about 18% in 2019 and 2018. Placements also slowed for the company.
Orthopaedic robotics companies, however, saw minimal impact to system placements during the pandemic, showing that hospitals were still willing to make the investment despite the economic hit from COVID-19.
While Intuitive has traditionally been the leader of the soft tissue robotics market and faced little competition, Medtronic and J&J are both entering the space. J&J unveiled its Ottava system in November 2020 and said first-in-human trials are planned to begin in the second half of 2022.
Competition is also coming from the smaller Vicarious Surgical, which has received funding from Bill Gates and Becton Dickinson. The company plans to make a 510(k) submission in 2023.
Despite the market competition, analysts still expect Intuitive to retain its global lead.