Boston Scientific Corporation announced FDA 510(k) clearance for the Asurys Fluid Management System, designed to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopies.
According to the company press release, ureteroscopy is a common procedure to diagnose and treat problems in the urinary tract, most commonly kidney stones. The Asurys System is designed 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, 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.”
In addition to ureteroscopies, the release states 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.
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