FRANKLIN LAKES, N.J.,
Jan. 18, 2018 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today announced the completion of
enrollment in the Lutonix below-the-knee (BTK) trial and plans to
submit a pre-market approval application in late 2018.
The Lutonix BTK trial is a prospective, multicenter, randomized,
controlled trial intended to demonstrate superior efficacy and
non-inferior safety of the Lutonix 014 Drug Coated Balloon (DCB) as
compared to standard angioplasty balloon catheters for treatment of
severe claudication and critical limb ischemia (CLI) patients with
stenotic or occlusive lesions in the below-the-knee arteries. The
Lutonix BTK trial is the only on-going DCB trial for BTK arteries
in the U.S. and has enrolled more than 450 patients over the past
four years.
The Lutonix 014 DCB product for BTK has been commercially
available in Europe, Canada and Australia for treatment of the arteries
associated with CLI since 2013.
CLI is a severe obstruction of the arteries that seriously
decreases blood flow to the lower leg arteries. An estimated 2
million people in the U.S. have CLI today, and the number is
estimated to grow to nearly 2.8 million by 2020i. CLI is
associated with major amputation rate of 10 percent to 40 percent
and with mortality rates as high as 50 percentii.
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
health care by developing innovative technology, services and
solutions that help advance both clinical therapy for patients and
clinical process for health care providers. BD and its 65,000
employees have a passion and commitment to help improve patient
outcomes, improve the safety and efficiency of clinicians' care
delivery process, enable laboratory scientists to better diagnose
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 health care. In 2017, BD welcomed C. R.
Bard and its products into the BD family. For more information on
BD, please visit bd.com.
Forward Looking Statements
This press release contains
certain estimates and other forward-looking statements (as defined
under Federal securities laws) regarding clinical trials and
product development activities and the regulatory approval process.
Forward looking statements may be identified by use of words such
as "intend", "plan", "believe", "expect" or other words of similar
meaning. All such statements are based upon the current
expectations of BD and involve a number of business risks and
uncertainties that could cause actual results to differ materially
from anticipated results described, implied or projected in any
forward-looking statement, including, without limitation,
difficulties inherent in product development and risks relating to
the regulatory approval process. We do not intend to update
any forward-looking statements to reflect events or circumstances
after the date hereof except as required by applicable laws or
regulations.
i Basser O, et al. Prevalence, Incidence, and
Outcomes of Critical Limb Ischemia in the US Medicare Population.
Vascular Disease Management 2013:10(2):E26-E36.
ii Teraa M, et al. Critical Limb Ischemia: Current
Trends and Future Directions. J Am Heart Assoc. 2016;5:e002938
Contacts:
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Troy
Kirkpatrick
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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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858.617.2361
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201.847.5378
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troy.kirkpatrick@bd.com
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Monique_Dolecki@bd.com
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SOURCE BD (Becton, Dickinson and Company)