Boston Scientific today announced FDA 510(k) clearance for the Asurys Fluid Management System, designed to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopies.
The Asurys System is the latest device in Boston Scientific's StoneSmart Solutions ecosystem of products to manage and treat kidney stones. It's designed to be paired with the LithoVue Elite Single-Use Digital Flexible Ureteroscope with IRP monitoring to aid in procedural IRP management.
"Based on feedback gathered through our work with urologists, we know measuring and managing intrarenal pressure (IRP) while maintaining irrigation flow for visualization is increasingly important," said Dr. Ronald Morton, chief medical officer, Urology, at Boston Scientific. "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 company said the Asurys System, when connected to the LithoVue Elite System, includes irrigation control from the scope handle, which is designed to reduce reliance on support staff. By pressing a button on the LithoVue Elite Ureteroscope, physicians can activate the on-demand flush feature to reposition stones into a better location for lithotripsy or basketing without manual irrigation.
In addition to ureteroscopies, the Asurys System can be used as an irrigation management option for cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures. Limited market release of the device in the U.S. will begin in the coming days.
