FDA grants clearance to Asurys Fluid Management System for endoscopic urologic procedures

The FDA has granted 510(k) clearance to the Asurys Fluid Management System to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopies, Boston Scientific announced.¹

The system is designed to automatically adjust irrigation flow based on real-time intrarenal pressure (IRP) readings obtained from the LithoVue Elite Single-Use Digital Flexible Ureteroscope with IRP monitoring. When paired with the LithoVue Elite system, the Asurys device modulates inflow to help maintain physician-defined pressure thresholds.

"Based on feedback gathered through our work with urologists, we know measuring and managing IRP while maintaining irrigation flow for visualization is increasingly important," said Ronald A. Morton, MD, chief medical officer, Urology, Boston Scientific, in the news release.¹ "Until now, there has not been a system that can automatically respond to IRP data in real-time. The Asurys Fluid Management System can automatically regulate irrigation inflow to help minimize the potential of exceeding physician-selected IRP settings."

The Asurys system is part of Boston Scientific’s StoneSmart™ platform, which includes devices for visualization, lithotripsy, and stone retrieval.

A notable feature of the Asurys system is the ability to control irrigation directly from the ureteroscope handle when paired with the LithoVue Elite System, including activation of an on-demand flush function. This may allow for repositioning of calculi during lithotripsy or basketing without reliance on manual irrigation adjustments by operating room staff. Additionally, the integrated ClariSee Flow Compensation feature is designed to automatically maintain a consistent irrigation flow rate when instruments occupy the working channel, which may otherwise reduce flow and impair visualization.²

"We're driven to advance urology for the long term by making meaningful improvements to patient outcomes while developing innovative technologies that equip and support care teams," added Meghan Scanlon, senior vice president and president, Urology, Boston Scientific, in the news release.¹ "The Asurys Fluid Management System is a clinical solution intended to streamline workflows and ultimately improve the treatment of kidney stone disease, all with the aim of reducing the cognitive burden for endourologists."

In addition to ureteroscopy, the system is also designed to be a single irrigation management system for cystoscopy, percutaneous nephrolithotomy, and benign prostatic hyperplasia procedures. According to Boston Scientific, limited market release of the device in the US will begin in the coming days.

REFERENCES

1. Boston Scientific receives FDA clearance for the Asurys™ Fluid Management System. News release. Boston Scientific Corporation. March 30, 2026. Accessed March 30, 2026. https://www.multivu.com/boston-scientific/9282251-en-boston-scientific-fda-clearance-asurys-fluid-management-system

2. Asurys Fluid Management System. Boston Scientific. Accessed March 30, 2026. https://www.bostonscientific.com/us/en/healthcare-professionals/products/fluid-management-systems/asurys-fluid-management-system/fp90000193.html