Medtronic, a global leader in healthcare technology, has officially announced that the Expand URO Investigational Device Exemption (IDE) clinical study, which also happens to be the largest such study for robotic-assisted urologic surgery ever conducted, has successfully met both its primary safety and effectiveness endpoints.
According to certain reports, this prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Medtronic’s Hugo™ robotic-assisted surgery (RAS) system.
Talk about the results during this exercise on a slightly deeper level, we begin from how, on an average, patients were approximately 63 years old and classified as American Society of Anesthesiologists (ASA) category ≥3, indicating they had severe systematic disease or condition impacting their overall health.
Next up, we must dig into the fact that 11 surgeons across 6 hospitals in the U.S. were able to use the technology for performing 3 distinct types of urologic procedures i.e. prostatectomies (prostate removal; n=55), nephrectomies (kidney removal; n=53), and cystectomies (bladder removal; n=29).
Another detail worth a mention stems from common patient cohorts being prostate cancer in prostatectomy, renal tumors in nephrectomy, and bladder tumors in cystectomy.
“The study demonstrated that the Hugo RAS system met the safety and effectiveness endpoints, and the outcomes are consistent with published literature for robotic-assisted urologic surgery,” said Dr. Michael R. Abern, M.D., the study’s national principal investigator and a urologic surgeon at Duke University Hospital in Durham, N.C.. “Having performed the first case in the Expand URO clinical study, it’s incredibly rewarding to see the results of this rigorous and important study in the field of robotic surgery.”
Moving on, we must also mention that Medtronic’s study was consistent with the FDA premarket requirements, included prospective enrollment and data collection, as well as independent event adjudication by a Clinical Events Committee (surgeon advisory group), data monitoring, along with top-notch follow-up compliance with approximately 98% of patients who completed the 30-day follow-up.
Markedly enough, the rates of grade 3 or higher complications (3.7% prostatectomy, 1.9% nephrectomy, and 17.9% cystectomy) were found to be favorably below the performance goals (20% prostatectomy, 20% nephrectomy, and 45% cystectomy; p=0.0006, p=0.0001, p=0.0025, respectively). For better understanding, these goals were established based on systematic review of published literature across all three cohorts.
Rounding up highlights would be a piece of data claiming that Medtronic study’s 98.5% surgical success rate was well above the performance goal of 85% (p<0.0001). In total, there were two conversions: one was related to the device and one was related to patient anatomy.
Among other things, we ought to mention how Medtronic thoughtfully designed the Hugo RAS system by leveraging partnerships with hundreds of surgeons and hospital leaders globally. This it did to expand access of minimally invasive care to a greater contingent of patients.
More on that would reveal how the technology delivers RAS’ innate value in a flexible, modular form factor, using an open surgeon console which supports communication among the surgical team.
On top of it, when paired with the Touch Surgery™ ecosystem, the Hugo RAS system effectively offers you a smart, connected surgical experience which is already shaping the future of surgery.
Outside of US, the Hugo RAS system is in clinical use across more than 25 countries, spanning 5 continents, with a growing body of evidence including more than 200 independent papers published to date.
“The Expand URO clinical study provides important clinical evidence about the Hugo RAS system and is an exciting milestone that brings us closer to our goal of offering surgeons in the U.S. long-awaited choice in robotic technology,” said James Porter, M.D., chief medical officer, Robotic Surgical Technologies and Digital Technologies within the Surgical business, part of the Medical Surgical portfolio at Medtronic. “Surgeons want to deliver the best care to our patients and robotic technology is key to making that possible today by enabling minimally invasive surgery and leveraging technology that is shaping the future of surgery.”
