Boston Scientific’s new kidney stone system gets FDA nod
Photo | Courtesy Boston Scientific
Boston Scientific headquarters, Marlborough
Boston Scientific Corp. has received clearance from the U.S. Food and Drug Administration for its new device designed to make kidney stone procedures safer and easier.
The Marlborough company announced the clearance of its LithoVue Elite Single-Use Digital Flexible Ureteroscope System on Feb. 3.
LithoVue Elite Single-Use Digital Flexible Ureteroscope System gives urologists the ability to monitor the internal pressure during a ureteroscopy procedure, which is used to diagnose and treat issues in the urinary tract, including kidney stones. During the procedure, internal pressure can elevate pressure in response to fluid irrigation, which is used so the urologist can see what is happening, and the elevated pressure can contribute to postoperative complications like systemic inflammatory response syndrome, sepsis, and renal damage.
The LithoVue Elite ureteroscope tip is designed to allow urologists to make decisions related to the pressure building during the procedure, according to Boston Scientific.
"We're at a critical moment in kidney stone care where patient demand is outpacing the number of urologists needed to address it," Meghan Scanlon, senior vice president and president, urology, Boston Scientific, said in the Feb. 3 press release. "We designed the next-generation LithoVue Elite System to bring a greater level of precision and functionality in the way urologists diagnose and treat kidney stones, an increasingly common condition among adults. We are committed to developing clinical solutions, like the LithoVue Elite System, that are intended to make procedures more efficient, empower surgical decisions, optimize patient care and ultimately improve the treatment of kidney stone disease globally."
The new system has a new high-resolution chip to provide faster and clearer images compared to previous LithoVue systems. It will have a new control system and will work with existing visualization towers and endoscopic monitors.
On Feb. 1 Boston Scientific announced in its annual earnings report its annual profits dropped from $1.04 billion in 2021 to $698 million in 2022. The company’s annual revenue did increase, though, from $11.9 billion in 2021 to $12.7 billion in 2022.
Boston Scientific will have limited market releases of the device in the U.S. in the coming weeks.
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