Philips and B. Braun receive FDA clearance for breakthrough
Onvision needle tip tracking technology for regional anesthesia
August 25, 2020
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.”
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.”
“Onvision is the groundbreaking technology that allows
anesthesiologists the predictability [4] and confidence [4] they
need while positioning the needle during a procedure,” said Dr.
Angela Karpf, M.D., Corporate Vice President 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 [3]. 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 [8]
and can reduce procedure times [4].
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. For more
information about Onvision visit bbraun.com/onvision.
[1] 2019Q2 All Regional Anesthesia Products – Total Market HC
& OPM Dollars (GHX, IQVIA [MDSA] & B. Braun Actual Data)[2]
Paqueron X. Time Sequence of Sensory Changes after Upper Extremity
Block. Anesthesiology 2004; 101:162-8[3] Test Report Validation -
NTT for PNB, Document Number: D000245353, Philips Medical Systems
Nederland B.V.[4] Kåsine, T., et al. Needle tip tracking for
ultrasound‐guided peripheral nerve block procedures—An observer
blinded, randomised, controlled, crossover study on a phantom
model. Acta Anaesthesiol Scand. 2019;00:1–8. https: //doi.
org/10.1111/aas.13379[5] Liu SS. Strodtbeck WM, Richman JM. Wu CL.
A comparison of regional versus general anesthesia for ambulatory
anesthesia: A meta-analysis of randomized control trials. Anesth
Analg. 2005 Dec;101(6):1634-42[6] Cohen NP, Levine WN, Marra G, et
al. Indwelling interscalene catheter anesthesia in the surgical
management of stiff shoulder: a report of 100 consecutive cases. J
Shoulder Elbow Surgery. 2000;9:268-274[7] Nielsen et al. Outcomes
after RA. Int Anesthesiol Clin. 2005 Summer; 43(3):96[8] Test
Report Validation - NTT for PNB, Document Number: D000245352,
Philips Medical Systems Nederland B.V.
Onvision needle is manufactured by B Braun and the Onvision
module for Xperius is manufactured by Philips. Onvision is a
registered trademark of B. Braun and Philips. Stimuplex is a
registered trademark of B. Braun Medical Inc.
For further information, please contact:
Hans DriessenPhilips Global Press OfficeTel.: +31 610 610
417E-mail: hans.driessen@philips.com Twitter: @hansdriessen_ph
Allison Longenhagen B. Braun Medical Inc.Tel.: +1 484 523
9801Email: Allison.Longenhagen@bbraunusa.com
About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health
technology company focused on improving people's health and
enabling better outcomes across the health continuum from healthy
living and prevention, to diagnosis, treatment and home care.
Philips leverages advanced technology and deep clinical and
consumer insights to deliver integrated solutions. Headquartered in
the Netherlands, the company is a leader in diagnostic imaging,
image-guided therapy, patient monitoring and health informatics, as
well as in consumer health and home care. Philips generated 2019
sales of EUR 19.5 billion and employs approximately 81,000
employees with sales and services in more than 100 countries. News
about Philips can be found at www.philips.com/newscenter.
About B. BraunB. Braun Medical Inc., a leader in infusion
therapy and pain management, develops, manufactures, and markets
innovative medical products and services to the healthcare
industry. Other key product areas include nutrition, pharmacy
admixture and dialysis. The company is committed to eliminating
preventable treatment errors and enhancing patient, clinician and
environmental safety. B. Braun Medical is headquartered in
Bethlehem, Pennsylvania and is part of the B. Braun Group of
Companies in the U.S., which includes B. Braun Interventional
Systems, Aesculap and CAPS.
Globally, the B. Braun Group of Companies employs more than
64,000 employees in 64 countries. Guided by its Sharing Expertise
philosophy, B. Braun continuously exchanges knowledge with
customers, partners and clinicians to address the critical issues
of improving care and lowering costs. To learn more about B. Braun
Medical, explore our website.
- Philips B. Braun Onvision Xperius regional anesthesia
- Philips B. Braun Onvision Xperius
- Philips B. Braun Onvision Xperius regional anesthesia needle
placement
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