FDA OKs Boston Scientific’s Asurys Fluid Management System for Urology

Boston Scientific revealed it has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Asurys fluid management system.

Designed for irrigation and distention during endoscopic urologic procedures, the Asurys system is the latest in the company’s StoneSmart suite of products used to manage and treat kidney stones. It can be merged with the LithoVue Elite single-use digital flexible ureteroscope to monitor intrarenal pressure (IRP) during a procedure.

Boston Scientific said the device responds to the challenge of maintaining fluid irrigation flow for clear visualization while keeping IRP low. Elevated IRP can contribute to post-op systemic inflammatory response syndrome (SIRS), sepsis, and renal damage.

“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.”

Asurys combined with LithoVue also lets surgeons control irrigation from the scope handle, helping to minimize relying on support staff. An on-demand flush feature can also be activated to reposition kidney stones into a more favorable 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.”

The system can also manage irrigation for cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures. The company said the device will launch on a limited basis within the week.

Earlier this year, Boston Scientific announced transactions to acquire urinary incontinence treatment device maker Valencia Technologies and mechanical thrombectomy product maker Penumbra.