Full Press Release Details
MARLBOROUGH, Mass. , Feb. 3, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX ) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with the ability to monitor intrarenal pressure in real-time during ureteroscopy procedures.
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"Multiple studies have shown the importance of understanding intrarenal pressure during ureteroscopy procedures to mitigate potential complications, but until now, urologists have lacked an easy way to measure pressure in real-time," said Ben Chew , M.D., M.Sc., associate professor, University of British Columbia . 5 "This device represents an important and needed advancement in single-use ureteroscopes, which could help improve patient care and potentially lead to a clearer understanding of the impact of elevated intrarenal pressure on patient outcomes."
The LithoVue Elite System, comprised of the single-use digital flexible ureteroscope and the StoneSmart™ Connect Console, builds on many of the features of the original LithoVue™ System with significant next-generation innovations. In addition to intrarenal pressure monitoring, device enhancements include:
The LithoVue Elite System is the latest device in the Boston Scientific single-use imaging portfolio, developed with physician feedback to advance patient care and eliminate infection risk associated with ineffective reprocessing of reusable scopes. It is also the first device built on the company's next-generation StoneSmart technology platform, intended to support potential interoperability with future Boston Scientific devices.
Limited market release of the device in the U.S. will begin in the coming weeks.
For more information about kidney stone solutions from Boston Scientific, please visit www.bostonscientific.com/LithoVueElite or StoneSmart.com .
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook .
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, clinical trials, product launches and product performance and impact. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Media Contact: Nate Gilbraith 701.212.9589
| References: |
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| 1 National Institute of Diabetes and Digestive and Kidney Diseases. Cystoscopy & Ureteroscopy. Available at: https://www.niddk.nih.gov/health-information/diagnostic-tests/cystoscopy-ureteroscopy . Accessed June 2022. |
| 2 National Kidney Foundation. Kidney Stones. Available at: https://www.kidney.org/atoz/content/kidneystones . Accessed July 2022. |
| 3 Tokas T, Herrmann TRW, Skolarikos A, et al. Pressure matters: intrarenal pressures during normal and pathological conditions, and impact of increased values to renal physiology. World J Urol . 2019 Jan;37(1):125-31. |
| 4 Proietti S, Dragos L, Somani B, et al. In vitro comparison of maximum pressure developed by irrigation systems in a kidney model. J Endourol. 2017 May;31(5):522-7. |
| 5 Dr. Ben Chew is a paid consultant of Boston Scientific Corporation. He has not been compensated for his quote within this press release. |
| 6 Romero, V., Akpinar, H., & Assimos, D. G. (2010). Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Reviews in urology , 12(2-3), e86–e96. |
SOURCE Boston Scientific Corporation