FRANKLIN LAKES, N.J.,
Jan. 24, 2019 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, announced the U.S. Food and Drug
Administration 510(k) clearance of its second generation BD Nano™
pen needle, designed for more reliable subcutaneous injection
depth.
BD Nano™ 2nd gen pen needles offer people who inject
diabetes medications a more reliable subcutaneous delivery of their
medication, designed to help people better manage their
diabetes.1 Recent updates to the 2019 American Diabetes
Association (ADA) Standards of Care highlight the importance of
proper injection technique as part of good diabetes
management.2 Proper injection technique is critical to
insulin's consistent absorption and there are several factors that
can inhibit predictable insulin uptake, including accidental
intramuscular injections, which can be caused by greater than
required injection force.
BD Nano 2nd gen pen needles help mitigate the risks
resulting from user injection force variability through its
contoured needle base and compensate for variable injection forces
by first concentrating, then distributing pressure closely around
the injection site (to support more reliable 4 mm target injection
depth compared to other 4mm pen needles1,3).
The new design has demonstrated more reliable subcutaneous
injection depth resulting in up to an 8-fold reduction in
calculated intramuscular injection
risk.1,4 Additionally, the new ergonomic
design of BD Nano 2nd gen makes it easier to use, from
attachment to disposal, compared to other pen needles, and results
in a more comfortable injection experience.5,6
"The launch of BD Nano 2nd gen pen needles reinforces
BD's commitment to providing the most advanced solutions possible
for people with diabetes to help achieve better clinical management
of insulin use," said Stanislav
Glezer, MD, MBA, global vice president of Medical Affairs
for BD. "In addition to the added clinical benefits the latest BD
innovation brings, the new ergonomic pen needle features can help
people feel more comfortable with their injection experience."
This latest advancement to the BD Nano portfolio includes all
the benefits its predecessor pen needle has, including BD's 32G x 4
mm pen needle with 5-bevel PentaPoint™ comfort, which has been
clinically shown to enter the skin more easily than other 3-bevel
needles, providing a smoother and more comfortable
injection, and extra thin wall EasyFlow™ technology that
increases the medication flow rate, making injections
easier.7,8 FDA 510(k) clearance will enable BD Nano
2nd gen pen needles to be commercially available in
mid-2019.
About BD
BD is one of the largest global medical technology companies in
the world and is advancing the world of health by improving medical
discovery, diagnostics and the delivery of care. The company
supports the heroes on the frontlines of healthcare by developing
innovative technology, services and solutions that help advance
both clinical therapy for patients and clinical process for
healthcare providers. BD and its 65,000 employees have a passion
and commitment to help enhance the safety and efficiency of
clinicians' care delivery process, enable laboratory scientists to
accurately detect disease and advance researchers' capabilities to
develop the next generation of diagnostics and therapeutics. BD has
a presence in virtually every country and partners with
organizations around the world to address some of the most
challenging global health issues. By working in close collaboration
with customers, BD can help enhance outcomes, lower costs, increase
efficiencies, improve safety and expand access to healthcare. In
2017, BD welcomed C. R. Bard and its products into the BD family.
For more information on BD, please visit
bd.com.
1Results from a BD
conducted, non-blinded, randomized, study measuring the depth of
1200, 90° injections comparing to several brands of 4 mm posted-hub
pen needles across several pre-specified target injection force
ranges; test performed on swine.
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2American Diabetes Association. 9.
Pharmacologic approaches to glycemic treatment: Standards of
Medical Care in Diabetes—2019. Diabetes Care 2019;42(Supp.
1):S90-S102.
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3(Target injection depth reliability
defined as injection percentage within 4.0 mm to 4.5 mm
inclusive).
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4Demonstrated range between
2x-8x across recommended injection sites: Abdomen, thigh,
arm, buttock, pooled across gender and BMI.
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5Results from a BD-sponsored,
non-blinded, randomized, home-use, 2-period crossover, patient
preference study with patients currently using 32G pen
needles. Total of 226 paid participants; superiority was
established with each subgroup.
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6Results from a BD-sponsored,
non-blinded, randomized, home-use, 2-period crossover, patient
preference study comparing 32G pen needles. Total of 226 paid
participants. Superiority/preference not demonstrated with
some subgroups.
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7Hirsch L, Gibney M, Berube J,
Manocchio J. The impact of a modified needle tip geometry on
penetration force as well as acceptability, preference and
perceived pain in subjects with diabetes, J Diab Sci Tech
2012;6(2);328-35.
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8Aronson R., et al. (2013).
Insulin pen needles. Effects of extra thin-wall needle
technology on preference, confidence, and other patient
ratings. Clinical Therapeutics, In Press, Corrected proof,
Available online 20 June 2013.
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Contacts:
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Matt
Coppola
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Monique N.
Dolecki
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BD Public
Relations
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BD Investor
Relations
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201.847.7370
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201.847.5378
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matthew.r.coppola@bd.com
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monique_dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)