BETHLEHEM, Pa., Aug. 25, 2020 /PRNewswire/ -- Royal Philips (NYSE: PHG, AEX: PHIA), a
global leader in health technology, and B. Braun Medical Inc., a
global market leader1 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 predictability4 and
confidence4 they need while positioning the needle
during a procedure," said Dr. Angela
Karpf, MD, 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
trajectory8 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 in the US visit
bbraunusa.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.
About B. Braun
B. 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.
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.
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SOURCE B. Braun Medical Inc.