Philips and B. Braun receive FDA clearance for breakthrough Onvision needle tip tracking technology for regional anesthesia

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Philips and B. Braun receive FDA clearance for breakthrough Onvision needle tip tracking technology for regional anesthesia

Press releases may be edited for formatting or style | August 25, 2020 Ultrasound
Amsterdam, the Netherlands – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, and B. Braun, a global market leader [1] in regional anesthesia and pain management, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Onvision, a breakthrough ultrasound guidance solution for real-time needle tip tracking. Available exclusively on the latest version of the B. Braun and Philips Xperius ultrasound system together with the dedicated Stimuplex Onvision needle, Onvision gives anesthesiologists the confidence to accurately position the needle tip inside the body for Peripheral Nerve Blocks (PNBs).

Accurate needle placement is critical to the success of regional anesthesia procedures such as PNBs. While real-time ultrasound imaging has proved to be a valuable tool for needle guidance, failure to optimally visualize the needle tip remains a challenge, with 10-15% of all PNBs ineffective after a single-injection technique [2]. In real-time, Onvision accurately indicates where the needle tip is inside the body, both in and out of the ultrasound viewing plane [3]. It helps the user align the needle with the probe in a user-friendly interface that can lead to a reduction in procedural time [4].

"When I first started to use Onvision, I didn't think that we would increase the number of out-of-plane procedures, but I was happily surprised we did," said Paul Kessler M.D. Ph.D., Vice Chairman, Clinic of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt (Germany). "Onvision gives you the extra assurance to perform deep and difficult blocks both in- and out-of-plane."

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FDA clearance for Onvision represents the latest advance in a multi-year strategic alliance between Philips and B. Braun to innovate in ultrasound-guided regional anesthesia, a rapidly growing alternative to general anesthesia. Regional anesthesia is an essential part of pain therapy and offers clear advantages when compared to general anesthesia such as pain elimination during and after surgery [5], improved functional outcomes [6], and faster mobilization [7].

"The increased confidence and predictability offered by the Xperius Ultrasound System and Onvision Needle Tip Tracking is empowering more anesthesiologists to embrace regional anesthesia as a viable and effective alternative to general anesthesia," said Tobin Taylor-Bhatia, Head of Innovation for Image Guided Therapy at Philips. "By innovating together with B. Braun we've created a solution to one of the biggest challenges in regional anesthesia – accurate positioning of the needle tip in the body."

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