Key Highlights
- First-ever U.S. IDE study in robotic hernia repair meets all primary safety and effectiveness endpoints
- 100% surgical success rate, zero SSEs in inguinal and just 2.1% in ventral repairs
- Medtronic poised to disrupt the $20B+ surgical robotics market with breakthrough data
A Landmark Clinical Study for Robotic Hernia Surgery
Medtronic’s Enable Hernia Repair trial is the first Investigational Device Exemption (IDE) study for robotic hernia repair in the U.S. The pivotal trial of 193 patients achieved a 100% surgical success rate, far surpassing the 85% target, and validated Hugo™ as a strong contender in robotic-assisted surgery.
Safety and Effectiveness Results Surpass Expectations
Zero surgical site events (SSEs) were reported in 92 inguinal patients, while just 2.1% were recorded among 94 ventral patients—both outperforming the 30% benchmark. Hospital stays were short, averaging 4.7 hours for inguinal and 6.7 hours for ventral repairs, highlighting efficiency in recovery and care delivery.
Expanding the Horizons of Robotic Surgery
With 1.5 million hernia repairs annually in the U.S., Hugo™’s clinical performance signals a major opportunity to expand minimally invasive care. Building on results from the Expand URO study and 300+ independent publications, Medtronic is shaping the future of robotic surgery with validated, surgeon-driven outcomes.
Medtronic’s Strategic Push into Surgical Robotics
Backed by its 75-year legacy, Medtronic is advancing Hugo™ as a global robotics platform. Already CE-marked in Europe and available in 30+ countries, the system awaits FDA clearance for urology, with hernia and gynecology indications in the pipeline. Success here could allow Medtronic to challenge incumbents and seize market share in a field projected to top $20B by 2030.
About Medtronic
Medtronic plc, headquartered in Galway, Ireland, is a global leader in healthcare technology with a mission to alleviate pain, restore health, and extend life. With more than 95,000 employees across 150+ countries, the company delivers advanced solutions in surgical robotics, cardiac devices, insulin pumps, patient monitoring, and more. Medtronic’s technologies treat over 70 health conditions and transform the lives of two people every second worldwide, reinforcing its 75-year legacy of innovation in patient care.
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