Boston Scientific Secures FDA Nod for Innovative Asurys™ Fluid Management System

Boston Scientific has secured FDA 510(k) clearance for its Asurys™ Fluid Management System, designed to enhance irrigation and distention during endoscopic urologic procedures, including ureteroscopies. Ureteroscopy is a prevalent method for diagnosing and treating urinary tract problems, especially kidney stones, which impact approximately one in ten individuals. One of the primary challenges in these procedures is ensuring adequate irrigation for clear visualization while maintaining low intrarenal pressure (IRP). High IRP levels can elevate the risk of post-operative complications, including systemic inflammatory response syndrome (SIRS), sepsis, and renal damage.

According to Precedence Research, the Flexible and Semi-Rigid Ureteroscopy Market was valued at USD 1.50 billion in 2025 and is projected to grow from USD 1.61 billion in 2026 to approximately USD 3.09 billion by 2035, expanding at a CAGR of 7.50% from 2026 to 2035, driven by increasing technology in healthcare.

Automated IRP Management with Asurys

Boston Scientific has unveiled the Asurys System, the latest enhancement to its StoneSmart Solutions portfolio for kidney stone management. When used alongside the LithoVue Elite Single-Use Digital Flexible Ureteroscope equipped with intrarenal pressure (IRP) monitoring, this innovative system aims to facilitate real-time management of IRP. Dr. Ronald Morton, Chief Medical Officer for Urology at Boston Scientific, highlighted that Asurys is the first system capable of automatically adjusting irrigation inflow based on IRP data, thereby improving visualization and minimizing the risk of surpassing physician-selected IRP thresholds.

Asurys™ for Multi Procedure Irrigation Control

The Asurys System, when integrated with the LithoVue Elite System, allows physicians to control irrigation directly from the scope handle, minimizing the need for support staff. With just the press of a button, doctors can initiate on-demand flushing to reposition stones for lithotripsy or basketing, eliminating the need for manual irrigation. Meghan Scanlon of Boston Scientific stated that the Asurys System is designed to enhance workflows, reduce cognitive load for endourologists, and improve the treatment of kidney stones. Additionally, the system can manage irrigation during cystoscopy, PCNL, and BPH procedures, with a limited release in the U.S. market set to begin soon.

A recent report by Precedence Research highlights that the Flexible & Semi-Rigid Ureteroscopy Market is benefiting from the increasing rate of kidney disorders.