Device is designed to regulate irrigation and intrarenal pressure during endoscopic urologic procedures
Boston Scientific has received US Food and Drug Administration (FDA) 510(k) clearance for the Asurys Fluid Management System, a device intended to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopy.
Ureteroscopy is commonly used to diagnose and treat urinary tract conditions, including kidney stones. Maintaining consistent irrigation flow while controlling intrarenal pressure (IRP) is a key challenge during these procedures. Elevated IRP has been associated with complications such as infection and renal damage.
“Based on feedback gathered through our work with urologists, we know measuring and managing IRP while maintaining irrigation flow for visualization is increasingly important,” says Ronald Morton, MD, chief medical officer of urology at Boston Scientific, in a release. “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 designed to automatically regulate irrigation inflow based on IRP data, with the goal of helping clinicians maintain pressure within a selected range while preserving visualization.
The system can be used in combination with the LithoVue Elite single-use digital flexible ureteroscope, which includes IRP monitoring. When connected, the system also allows clinicians to control irrigation from the scope handle, including activating a flush feature to reposition stones during procedures.
In addition to ureteroscopy, the system is indicated for use in cystoscopy, percutaneous nephrolithotomy, and benign prostatic hyperplasia procedures.
Boston Scientific says a limited US market release is expected to begin in the coming days.
