Medtronic confirmed that its Hugo surgical robot system has been submitted to the FDA for review, alongside the successful completion of a large clinical trial evaluating its performance in multi-port urologic procedures.
The medtech giant’s U.S. study, dubbed Expand URO, included patients with different types of cancer, who underwent the surgical removal of their prostate, kidney or bladder tissue. It enrolled its first participant in late 2022.
According to the company, Hugo’s robotic assistance led to a 98.5% surgical success rate, alongside lower rates of serious complications when compared to historical averages across published scientific literature.
Out of 137 patients, Medtronic noted two mid-procedure conversions from the Hugo system to another surgical approach—once due to the device, and once necessitated by the patient’s anatomy. The company said the study’s participants with cancer would be followed for up to five years.
The results were presented this past weekend at the annual meeting of the American Urologic Association, being held in Las Vegas.
Urology will serve as Hugo’s entry point in Medtronic’s strategy for competing in the U.S. market. Looking ahead, CEO Geoff Martha noted during the company’s quarterly earnings call in February that it has completed enrolling patients into studies for hernias as well as benign gynecological procedures—and that Medtronic also received the FDA’s permission to conduct a pivotal trial in gynecological cancers.
The cart-based, portable and modular system previously obtained a CE Mark approval in Europe in October 2021, for urologic as well as gynecologic procedures, after being used in Latin and South America and India. The company said Hugo has so far been tapped for surgeries in more than 25 countries across five continents, with procedure volume doubling year-over-year.