Calyxo receives FDA approval for redesign of device that collects kidney stone fragments
Key takeaways
- Calyxo Inc. has received FDA approval for a device that collects kidney stone fragments after laser lithotripsy.
- Approximately 10% of people in the United States will have a kidney stone.
Calyxo Inc. has received FDA approval for a device that sweeps up kidney stone fragments after laser lithotripsy, according to a company press release.
More than 50 procedures have been completed by 12 urologists with the new Calyxo vacuum system, which is known as the CVAC system, according to the company.
“The most commonly used kidney stone treatments today do not reliably remove all of the stone fragments and dust,” Brian Eisner, MD, director of the kidney stone program at Massachusetts General Hospital and founding clinical advisor to Calyxo, said in the release. “We know that vacuum aspiration of stone fragments during ureteroscopy with laser lithotripsy under direct visualization provides unique advantages to enable better stone clearance for our patients who, in some cases, will experience a less invasive procedure with a decreased need for additional treatments.”
According to Calyxo, studies have shown that residual stone fragments are associated with a 20% to 44% incidence of post-procedure problems including pain, infection, ED visits, hospitalization and the need for retreatment.
Approximately 10% of people in the United States will have a kidney stone at some point in their lives, according to the National Kidney Foundation.
“Ureteroscopy, the most common procedure done for kidney stones, is suboptimal when it comes to fragment removal,” Eisner told Healio. “By creating a vacuum, we can remove more fragments during ureteroscopy and may be able to treat some larger stones that would have required a more invasive procedure such as [percutaneous nephrolithotomy] with ureteroscopy with similar outcomes,” Eisner said.
Eisner told Healio the second-generation device approved by the FDA “is a huge advancement and with great advantages over the first-generation device.”
The first-generation device was used to successfully treat more than 1,500 patients in the United States, “demonstrating that vacuum aspiration of stone fragments improves clinical outcomes, with 97% volumetric stone clearance and a high likelihood of avoiding the need for a secondary or more invasive procedure,” according to the release.
Reference:
National Kidney Foundation. https://www.kidney.org/atoz/content/kidneystones. Accessed March 27, 2024.
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