Boston Scientific receives FDA clearance for the Asurys Fluid Management System in endoscopic urology
Boston Scientific announced FDA 510(k) clearance for the Asurys Fluid Management System, designed to provide irrigation and distention during endoscopic urologic procedures, including ureteroscopies.
Ureteroscopy is a common procedure to diagnose and treat problems in the urinary tract, most commonly kidney stones.1 Research shows that about one in 10 people will develop a kidney stone at some point in their lives. One challenge during ureteroscopy is maintaining fluid irrigation flow for clear visualization while keeping intrarenal pressure (IRP) low to help promote safe patient care.Elevated IRP may contribute to a range of post-operative complications including systemic inflammatory response syndrome (SIRS), sepsis and renal damage.
The Asurys System is the latest device in Boston Scientific’s StoneSmart™ Solutions ecosystem of products to manage and treat kidney stones. When paired with the LithoVue Elite Single-Use Digital Flexible Ureteroscope with IRP monitoring, 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.”
Another integrated feature of 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.
“We’re driven to advance urology for the long term by making meaningful improvements to patient outcomes while developing innovative technologies that equip and support care teams,” said Meghan Scanlon, senior vice president and president, Urology, Boston Scientific. “The Asurys Fluid Management System is a clinical solution intended to streamline workflows and ultimately improve the treatment of kidney stone disease, all with the aim of reducing the cognitive burden for endourologists.”
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.
