Ureteroscopic procedures are the most common surgical stone procedures globally but become increasingly challenging as stone size increases. Percutaneous nephrolithotomy (PCNL) procedures have demonstrated superior stone clearance for patients with larger kidney stones, but still represent a small portion of the total stone procedures conducted due to numerous barriers. Now, a new robotic platform that supports both ureteroscopic and PCNL procedures overcomes many of these obstacles by using unique and minimally invasive technology.

The MONARCH Platform from Auris Health, Inc., a subsidiary of Ethicon, Inc., a Johnson & Johnson MedTech (New Brunswick, NJ, USA) company, is designed to enable urologists to reach and visualize areas within the kidney with precision and control. Since 2018, physicians have used MONARCH to perform robotically assisted bronchoscopy procedures and reach small, hard-to-reach peripheral lung nodules at an earlier stage and with greater precision than ever before. MONARCH Platform has now received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for endourological procedures, making it the first and only multispecialty, flexible robotic solution for use in both bronchoscopy and urology.

“This latest FDA 510(k) clearance for MONARCH delivers on our vision to extend the robotic platform’s capabilities across multiple specialties, enabling hospital systems to target two disease states using one device,” said Vladimir Makatsaria, Company Group Chairman, Ethicon. “At Ethicon, we’re committed to driving meaningful innovation that elevates the standard of care for patients and delivers improved solutions that address important clinical challenges for our customers.”

“With this FDA clearance, MONARCH is poised to aid physicians in their goals of reducing overall retreatment and complication rates,” said Jaime Landman, MD, Chairman & Professor, Department of Urology at University of California Irvine. “Furthermore, as physicians strive to elevate the standard of care and improve outcomes, MONARCH supports them in their primary goal of rendering patients stone free in a single procedure.”

“MONARCH reduces the complexity of gaining high-quality percutaneous access and aids stone clearance efficiency through simultaneous fragmentation and suctioning of stones with robotic assistance,” said Mihir Desai, MD, Professor of Clinical Urology, University of Southern California. “With this platform, many urologists may be willing to expand their practice to include percutaneous access and PCNL procedures, thereby increasing patient access to more effective treatments closer to home.”

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