Boston Scientific Receives FDA Clearance for Asurys Fluid Management System to Address Kidney Stone Treatment Challenges
核心洞察
Boston Scientific Corporation received FDA 510(k) clearance for the Asurys Fluid Management System (搜索), designed to provide automated irrigation management during endoscopic urologic procedures including ureteroscopy for kidney stone treatment.
The system addresses a critical clinical challenge by automatically regulating irrigation inflow to help minimize intrarenal pressure (搜索), which can contribute to serious post-operative complications including sepsis (搜索) and renal damage.
When paired with the LithoVue Elite Single-Use Digital Flexible Ureteroscope (搜索), the Asurys System enables real-time intrarenal pressure (搜索) monitoring and automated response, representing the first system capable of automatically responding to pressure data during procedures.
Boston Scientific Corporation announced FDA 510(k) clearance for the Asurys Fluid Management System (搜索), a new technology designed to address critical safety challenges in kidney stone treatment procedures. The system represents a significant advancement in urologic care by providing automated irrigation management during endoscopic procedures, with particular focus on maintaining safe intrarenal pressure (搜索) levels.
Addressing Critical Safety Challenges in Ureteroscopy
Ureteroscopy, a common procedure to diagnose and treat urinary tract problems, most commonly kidney stones (搜索), affects a substantial patient population. Research indicates that approximately one in 10 people will develop a kidney stone at some point in their lives. However, the procedure presents significant technical challenges that can impact patient safety.
One of the primary challenges during ureteroscopy involves maintaining adequate fluid irrigation flow for clear visualization while keeping intrarenal pressure (搜索) (IRP) low to promote safe patient care. Elevated IRP can contribute to a range of serious post-operative complications including systemic inflammatory response syndrome (搜索) (SIRS), sepsis (搜索), and renal damage.
Innovative Real-Time Pressure Management Technology
The Asurys System represents the first technology capable of automatically responding to intrarenal pressure (搜索) data in real-time. When paired with the LithoVue Elite Single-Use Digital Flexible Ureteroscope (搜索) with IRP monitoring, the system can automatically regulate irrigation inflow to help minimize the potential of exceeding physician-selected IRP settings.
"Based on feedback gathered through our work with urologists, we know measuring and managing intrarenal pressure (搜索) (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."
Enhanced Procedural Efficiency and Workflow Integration
The Asurys System incorporates several features designed to streamline surgical workflows and reduce procedural complexity. When connected to the LithoVue Elite System, the device includes irrigation control directly from the scope handle, which is designed to reduce reliance on support staff. Physicians can activate an on-demand flush feature by pressing a button on the LithoVue Elite Ureteroscope, allowing them to reposition stones into better locations for lithotripsy or basketing without manual irrigation.
"The Asurys Fluid Management System (搜索) 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," said Meghan Scanlon, senior vice president and president, Urology, Boston Scientific.
Broad Clinical Applications
Beyond ureteroscopy procedures, the Asurys System can be utilized as an irrigation management option for multiple urologic procedures including cystoscopy, percutaneous nephrolithotomy (PCNL), and benign prostatic hyperplasia (搜索) (BPH) procedures. This versatility positions the device as a comprehensive solution for various endoscopic urologic interventions.
The device is part of Boston Scientific's StoneSmart Solutions ecosystem of products designed to manage and treat kidney stones (搜索), representing the company's continued investment in advancing urologic care technologies.
Market Introduction and Clinical Impact
Limited market release of the Asurys Fluid Management System (搜索) in the United States will begin in the coming days following the FDA clearance. The introduction of this technology addresses a significant unmet clinical need in urologic procedures, where the balance between adequate visualization and patient safety has been a persistent challenge.
The system's ability to provide automated, real-time pressure management represents a meaningful advancement in procedural safety for the substantial population of patients requiring kidney stone treatment and other urologic interventions.