Auris Health,, a subsidiary of Ethicon, Inc., a Johnson & Johnson MedTech company, said that its MONARCH Platform received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for endourological procedures. This clearance makes MONARCH the first multispecialty, flexible robotic solution for use in both bronchoscopy and urology. It is designed to enable urologists to reach and visualize areas within the kidney with precision and control.
“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 provides urologists with one platform that supports both ureteroscopic and percutaneous nephrolithotomy (PCNL) procedures. Ureteroscopic procedures are the most common surgical stone procedures globally but become increasingly challenging as stone size increases. PCNL procedures have demonstrated superior stone clearance for patients with larger kidney stones, yet they represent only 7-8% of stone procedures conducted in the U.S. today.
Numerous barriers hinder more frequent use of PCNL. MONARCH overcomes many of these obstacles by using unique and minimally invasive technology.
“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.”
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.
Following this approval, Ethicon expects to initiate a first-in-human clinical study later this year for the MONARCH Platform’s endourologic application.