FDA Clears First Robotic LigaSure Vessel Sealer

FDA has cleared Medtronic’s LigaSure RAS Maryland instrument for use with the Hugo robotic-assisted surgery system, the company announced 16 September 2026 — the first time a robotically-driven LigaSure vessel-sealing instrument has reached the U.S. market. The clearance ties a technology already used in tens of millions of open and laparoscopic procedures to a robotic platform still building out its American footprint, nine months after Hugo itself won its first U.S. indication.

An established energy platform, a newer robot

LigaSure is not a new technology. Medtronic’s vessel-sealing instruments, which use bipolar energy and pressure to fuse vessel walls rather than relying on sutures or clips, have been a fixture of open and laparoscopic surgery for roughly twenty years, and the company counts more than 45 million procedures across more than 65 countries using the platform. What is new is the delivery mechanism: the RAS Maryland instrument adapts that sealing technology to a robotic arm on Hugo, Medtronic’s robotic-assisted surgery system, rather than a handheld or laparoscopic grip.

The cleared instrument seals and cuts blood vessels, thick tissue bundles and lymphatic tissue up to and including 7 millimeters in diameter, completing a seal in about two seconds while the device is designed to limit thermal spread into adjacent tissue — a standard specification for energy-based sealing devices, where minimizing collateral heat damage during dissection is a persistent surgical concern. The instrument is restricted to Medtronic’s own Valleylab FT10 generator on the Hugo platform, a labeling detail that keeps the energy source and the sealing instrument within a single validated system rather than opening compatibility to third-party generators.

Hugo's slow build-out of U.S. indications

The clearance lands nine months after Hugo won its first American indication. FDA cleared the Hugo RAS system for minimally invasive urologic surgical procedures — prostatectomy, nephrectomy and cystectomy, together accounting for roughly 230,000 U.S. surgeries a year — on 3 December 2025, on the strength of the Expand URO investigational device exemption study, which the company has described as the largest completed U.S. clinical study of multi-port robotic-assisted urological surgery. Since then Medtronic has said it intends to pursue additional indications in general and gynecologic surgery, with a hernia-repair study already registered in clinical trials.

• 3 December 2025: FDA clears Hugo RAS for urologic procedures (prostatectomy, nephrectomy, cystectomy), Medtronic's first U.S. Hugo indication.
• 2025: LigaSure RAS Maryland receives CE Mark in Europe, ahead of its U.S. clearance.
• 16 September 2026: FDA clears LigaSure RAS Maryland for use with Hugo in the U.S., restricted to the Valleylab FT10 energy platform.
• Ongoing: Medtronic has a hernia-repair study registered for Hugo (Enable Hernia Repair) and has said it will pursue general-surgery and gynecologic indications next.

Why an instrument clearance matters on its own

A robotic surgery platform’s market reach is set as much by its instrument catalog as by the base system’s own indication. A robot cleared for a procedure type is not useful in practice without the individual sealing, cutting and grasping instruments surgeons need for that operation, and each of those instruments typically requires its own 510(k) clearance layered on top of the platform’s. The LigaSure RAS Maryland clearance is one such layer: it does not expand what procedures Hugo is indicated for, but it gives surgeons already using Hugo for urologic cases access to an energy-sealing instrument built on a technology base with two decades of use elsewhere in Medtronic’s portfolio, rather than a Hugo-specific sealing tool developed from scratch.

Frequently asked questions

What did FDA clear on 16 September 2026?

Medtronic's LigaSure RAS Maryland instrument for use with the Hugo robotic-assisted surgery (RAS) system. It is described as the first robotically-driven LigaSure instrument to reach the U.S. market, bringing Medtronic's LigaSure vessel-sealing technology onto a robotic platform for the first time domestically.

What does the instrument do?

It seals and cuts blood vessels, thick tissue and lymphatic tissue up to and including 7 millimeters in diameter, sealing a vessel in roughly two seconds while limiting thermal spread to surrounding tissue. It is built to work only with the Valleylab FT10 energy platform on the Hugo RAS system.

Is this the same LigaSure technology used in open and laparoscopic surgery?

Yes. Medtronic describes LigaSure vessel-sealing technology as having been used in more than 45 million procedures across more than 65 countries over roughly two decades in its handheld and laparoscopic forms. The RAS Maryland instrument adapts that same energy-based sealing technology to a robotic instrument arm.

What is the Hugo RAS system's U.S. status?

FDA cleared Hugo for minimally invasive urologic procedures — including prostatectomy, nephrectomy and cystectomy — on 3 December 2025, based on the Expand URO investigational device exemption study. Medtronic has said it plans to pursue additional U.S. indications for Hugo in general and gynecologic surgery, including hernia repair, which is already in clinical study.