The FDA has issued 510(k) clearance to Onvision, a breakthrough ultrasound guidance solution for real-time needle tip tracking from Royal Philips and B. Braun. Onvision is available exclusively on the latest version of the B. Braun and Philips Xperius ultrasound system. The device is expected to be available in the US by the end of 2020.

“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),” according to Philips, which added that 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. In real-time, Onvision accurately indicates where the needle tip is inside the body, both in and out of the ultrasound viewing plane. It helps the user align the needle with the probe in a user-friendly interface that can lead to a reduction in procedural time.

“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 MD, PhD, Vice Chairman, Clinic of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt. “Onvision gives you the extra assurance to perform deep and difficult blocks both in- and out-of-plane.”

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, improved functional outcomes, and faster mobilization.

“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.”

“Onvision is the groundbreaking technology that allows anesthesiologists the predictability [4] and confidence [4] they need while positioning the needle during a procedure,” said Angela Karpf, MD, corporate VP of Medical Affairs at B. Braun. “B. Braun continues to add products to our regional anesthesia therapy portfolio that help achieve faster postsurgical recoveries, optimize procedural workflow and enhance user experience.”

Together, B. Braun’s Stimuplex Onvision needles and Philips’ Onvision needle tip tracking technology indicate the position of the needle tip in relation to the ultrasound viewing plane to an accuracy of 3mm. A sensitive micro-sensor placed on the needle, combined with advanced signal processing and visualization techniques on the Xperius system, indicate the real-time location of the needle tip in relation to the 2D ultrasound viewing plane. The solution provides greater flexibility in needle trajectory and can reduce procedure times.

In addition to FDA clearance, the Onvision solution is CE marked. It is available for sale across the EU and in Chile and is expected to be available in the United States in Q4 2020.