Boston Scientific Corporation (NYSE: BSX) received U.S. Food and Drug Administration 510(k) clearance for its Asurys Fluid Management System, designed to provide irrigation and distention during endoscopic urologic procedures including ureteroscopies.

The device is intended for use in ureteroscopy, cystoscopy, percutaneous nephrolithotomy and benign prostatic hyperplasia procedures. When paired with Boston Scientific's LithoVue Elite Single-Use Digital Flexible Ureteroscope, the system can monitor intrarenal pressure and automatically regulate irrigation inflow based on physician-selected pressure settings.

The system includes an irrigation control feature accessible from the scope handle, allowing physicians to activate an on-demand flush function to reposition kidney stones during procedures without manual irrigation assistance.

"Until now, there has not been a system that can automatically respond to IRP data in real-time," said Dr. Ronald Morton, chief medical officer for urology at Boston Scientific. "The Asurys Fluid Management System can automatically regulate irrigation inflow to help minimize the potential of exceeding physician-selected IRP settings."

The device addresses challenges in ureteroscopy procedures, where maintaining proper fluid flow for visualization while controlling intrarenal pressure is important for patient safety. Elevated intrarenal pressure may contribute to post-operative complications including systemic inflammatory response syndrome, sepsis and renal damage.

Boston Scientific plans to begin limited market release of the Asurys System in the United States in the coming days. The device is part of the company's StoneSmart Solutions ecosystem for kidney stone management and treatment.