Boston Scientific has secured 510(k) clearance from the US Food and Drug Administration for its Asurys system, a fluid management platform designed to support irrigation and distention during endoscopic urologic procedures such as ureteroscopy. The clearance positions the Asurys system as a new addition within the company’s StoneSmart Solutions product ecosystem, which focuses on kidney stone management and treatment. The system is intended to help clinicians maintain consistent irrigation flow while managing intrarenal pressure (IRP), two factors considered critical during such procedures.
The Asurys system can be integrated with the LithoVue Elite single-use digital flexible ureteroscope, enabling real-time monitoring of intrarenal pressure. When paired, physicians can directly control irrigation from the scope handle, streamlining procedural workflows. The platform also includes an on-demand flush feature, activated via the ureteroscope, allowing repositioning of stones without requiring manual irrigation or assistance from support staff. Beyond ureteroscopy, the system is indicated for use in percutaneous nephrolithotomy (PCNL), cystoscopy, and benign prostatic hyperplasia (BPH) procedures.
Boston Scientific indicated that a limited market release of the Asurys system in the US will begin in the coming days. The company emphasised the system’s ability to respond dynamically to procedural requirements, particularly in maintaining irrigation efficiency while controlling pressure levels.
Boston Scientific Urology chief medical officer Dr Ronald Morton said: “Based on feedback gathered through our work with urologists, we know measuring and managing intrarenal pressure (IRP) while maintaining irrigation flow for visualisation is increasingly important.
“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 minimise the potential of exceeding physician-selected IRP settings.”
Earlier this year, Boston Scientific also reported data outlining the benefits of spinal cord stimulation (SCS) therapies within its neuromodulation portfolio.
