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Boston Scientific's Asurys™ Fluid Management System Receives FDA Clearance

Boston Scientific Corporation, a leader in medical innovation, has recently announced that its Asurys™ Fluid Management System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new technology aims to enhance irrigation management during various endoscopic urologic procedures, such as ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL), and treatment for benign prostatic hyperplasia (BPH).

Revolutionizing Urologic Procedures

The Asurys System is designed to provide critical irrigation and distention during these procedures, addressing a vital component: managing the intrarenal pressure (IRP). Ureteroscopy is a frequently performed procedure to diagnose and treat urinary tract issues, such as kidney stones, affecting nearly 10% of people at some stage of their lives. With the Asurys system, Boston Scientific is stepping up to tackle one of the persistent challenges in ureteroscopy: ensuring smooth fluid irrigation to maintain clear visibility while keeping the intrarenal pressure at a safe level. This balance is crucial for preventing potential post-operative complications, including systemic inflammatory response syndrome (SIRS) and renal damage.

Innovative Features and User-Centric Design

The Asurys Fluid Management System is part of Boston Scientific's broader StoneSmart™ Solutions suite aimed at managing kidney stones effectively. Notably, when paired with the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope— which features monitoring for intrarenal pressure—this integrated system allows for real-time responses to IRP fluctuations.

Dr. Ronald Morton, Chief Medical Officer for Urology at Boston Scientific, emphasized the importance of adaptively managing intrarenal pressure while maintaining irrigation flow. He noted that until now, there has been no system that provides automatic IRP data response in real-time. The Asurys System stands to eliminate this gap, prompting timely adjustments of irrigation inflow to reduce the risk of surpassing user-defined IRP settings.

Another significant advancement that the Asurys System brings is irrigation control directly through the handle of the LithoVue Elite Ureteroscope. This enhancement is expected to reduce the need for additional staff support during procedures, thereby streamlining operations. Physicians can easily initiate on-demand flushing to reposition stones for more effective lithotripsy or basketing, all while minimizing manual irrigation efforts.

Commitment to Improving Patient Care

Boston Scientific's commitment to enhancing urology care is apparent in the development of technologies aimed at improving patient outcomes. Meghan Scanlon, Senior Vice President and President of Urology, noted, "The Asurys Fluid Management System is designed not only to refine workflow efficiency but also to optimize the treatment of kidney stone disease, alleviating the cognitive load on endourologists."

Beyond ureteroscopy, the system shows versatility as an irrigation management solution for a variety of urology procedures, including cystoscopy, PCNL, and BPH interventions. The limited market release of the Asurys System in the U.S. is anticipated to commence shortly, and more information is available on Boston Scientific’s official websites.

About Boston Scientific

Founded over 45 years ago, Boston Scientific focuses on transforming lives through innovative medical technologies. The company is committed to advancing healthcare solutions that cater to various needs in cardiovascular, respiratory, neurological, and urological treatments, among other areas. Discover more about their extensive portfolio and commitment to improving health outcomes at Boston Scientific.