Philips (NYSE:PHG) and B. Braun Medical announced that the FDA has cleared Onvision ultrasound guidance software for real-time needle tip tracking. Available on the latest version of the B. Braun and Philips Xperius ultrasound system, together with the dedicated Stimuplex Onvision needle, Onvision was designed to enable anesthesiologists 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, according to a 2004 study published in the journal Anesthesiology.
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, according to the companies. A 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 trajectory8 and can reduce procedure times, they added.
FDA clearance for Onvision represents the latest advance in a multi-year strategic alliance between Philips and B. Braun in ultrasound-guided regional anesthesia, a rapidly growing alternative to general anesthesia.
“The increased confidence and predictability offered by the Xperius ultrasound system and Onvision needle tip tracking (are) 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, in a news release. “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 predictability4 and confidence4 they need while positioning the needle during a procedure,” added Dr. Angela Karpf, 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.”
Onvision software is CE marked and is available for sale across the EU and in Chile and is expected to be available in the United States in Q4 2020.