Medtronic Seeks Expanded Indications for Hugo Robotic-Assisted Surgical System

Medtronic is working to expand indications for its Hugo robotic-assisted surgery (RAS) system in the United States. The company today announced several initiatives toward that goal, including:

• General surgery indication including hernia repair—U.S. Food and Drug Administration (FDA) 510(k) clearance proposal submitted
• Embrace Gynecology FDA Investigational Device Exemption (IDE) clinical study—completed enrollment
• Gynecologic surgery indication—FDA 510(k) clearance proposal submitted
• LigaSure RAS Maryland instrument—FDA 510(k) clearance application submitted
• ProGrip Advanced mesh for use in robotic-assisted ventral hernia repair—FDA 510(k) clearance received

These initiatives build momentum for the launch of Medtronic’s Hugo RAS system, which received FDA clearance for urologic surgical procedures in December and is used at U.S. medical centers. With nearly five years of commercial experience in more than 35 countries across five continents, the Hugo RAS system has been used in tens of thousands of procedures. Hundreds of independently-published scientific papers support the system’s safety and effectiveness.

“These milestones and technologies will unlock our ability to enhance the value of our partnership in general and gynecologic surgical procedures,” said Matt Anderson, senior vice president/president of Medtronic’s Surgical business. “This isn’t just a portfolio expansion; it’s part of our commitment to unite instruments, intelligence, and human hands into one surgical ecosystem. One that enables every patient, everywhere, access to the best possible surgery.”

Expanding Hugo RAS Indications and Capabilities

The 510(k) filings for Hugo RAS system use in general surgery and gynecological procedures would significantly broaden the platform’s U.S. clinical applicability and address growing demand for robotic-assisted minimally invasive options in these high-volume specialties, according to bigwigs. They are also indications where the Hugo RAS system is in clinical use in major markets outside the United States. 

To continually enhance Hugo RAS system’s capabilities, Medtronic has submitted an FDA 510(k) filing for the LigaSure RAS Maryland instrument. Designed exclusively for use with the Valleylab FT10 energy platform on the Hugo RAS system, LigaSure RAS incorporates vessel-sealing technology that has been used in more than 35 million procedures across 65-plus countries. LigaSure RAS was introduced on the Hugo RAS system in Europe last year.

“LigaSure technology has been transformative for surgery and integrating it onto the Hugo RAS system gives surgeons greater confidence and control during critical moments in complex procedures,” said Dr. Matthew Kroh, chief medical officer within Medtronic’s Surgical business and a practicing general surgeon. “As more and more surgeons and patients demand robotic-assisted surgery, we need more access to technology and training, and Medtronic brings that choice in a very powerful way.”

The Most Advanced Robotic Mesh^1-3,†

Medtronic also has received FDA clearance for ProGrip Advanced, an evolution of existing mesh technologies to better align with the specific demands of robotic-assisted ventral hernia repair.

ProGrip meshes have been used in more than 6 million procedures. ProGrip Advanced supports surgical efficiency in robotic procedures by making it easier to introduce through trocars, handle, deploy, and unfold compared to previously available products and comes in various sizes to meet each patient’s needs.^2-3,‡

Nearly 470,000 U.S. ventral hernia repair procedures are performed annually, more are conducted with robotic assistance, and an increasing number are performed at alternative sites of care as hospitals shift lower-acuity procedures to ambulatory surgical centers to support a patient-centered approach to care while managing cost pressures and capacity challenges. The Medtronic surgical ecosystem across open, laparoscopic, and robotic-assisted surgery is positioned to help solve these problems.

In addition to the regulatory clearance for ProGrip Advanced, Medtronic also has completed enrollment in the Embrace Gynecology Investigational Device Exemption (IDE) U.S. clinical study for the Hugo RAS system. Embrace Gynecology is a prospective multicenter study to evaluate the Hugo RAS system’s efficacy in robotic-assisted gynecologic procedures. The study enrolled 70 patients in five U.S. hospitals.

Headquartered in Galway, Ireland, Medtronic is the world’s largest global healthcare technology company that employs more than 95,000 workers across more than 150 countries. Its technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. The company delivers technologies that transform the lives of two people every second, every hour, every day.

† Compared to all Medtronic meshes indicated for robotic ventral hernia repair.
‡ Bench testing may not be indicative of clinical performance.

References
¹ Based on internal report 43463CR757, Memorandum — ProGrip™ advanced self-gripping polypropylene mesh — advanced robotic mesh.
² Based on internal report 43463CR506, Design verification report. 
³ Based on internal report 43463CR740, Design validation lab of ProGrip™ advanced self-gripping polypropylene mesh by MIS and open surgical approach.