FRANKLIN LAKES, N.J.,
Sept. 28, 2019 /PRNewswire/
-- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading
global medical technology company, today announced the publication
of a company-initiated, independent analysis of the
LUTONIX® 035 Drug Coated Balloon (DCB)
femoropopliteal clinical program in the Journal of the
American College of Cardiology (JACC): Cardiovascular
Interventions. These data were simultaneously presented in
a late-breaking session at Transcatheter Cardiovascular
Therapeutics (TCT), the annual scientific symposium of the
Cardiovascular Research Foundation.
This independent analysis evaluated LUTONIX® 035 DCB
(N=1093) and standard percutaneous transluminal angioplasty (PTA)
(N=250) safety outcomes using patient-level data and
propensity-matching from three LUTONIX® DCB randomized,
controlled trials: LEVANT 1, LEVANT 2 and LEVANT Japan, as well as the Continued Access cohort
of the LEVANT 2 trial, and confirmed that there was no
statistically significant increase in mortality with the use of
LUTONIX® 035 DCB.
"While the FDA and Advisory Committee of Circulatory System
Devices Panel in June identified a late mortality signal after
treatment with paclitaxel-coated devices using a meta-analysis of
randomized, controlled trials at five years from multiple
companies, they recognized the benefits of these devices, including
fewer reinterventions. They agreed that the magnitude of the signal
should be interpreted with caution due to multiple limitations in
the available data," said Kenneth
Ouriel, MD, president and CEO, Syntactx, the clinical
research firm that conducted the independent analysis, and former
chairman of Surgery at the Cleveland Clinic. "This large
patient-level analysis found no statistically significant increase
in mortality associated with LUTONIX DCB treatment. LUTONIX DCB
remains a viable medical therapy for patients with peripheral
arterial disease who demonstrate a high risk for restenosis and
repeat femoropopliteal interventions."
Further, a medical advisory committee comprised of an
interventionalist and oncologist re-evaluated the cause of death in
the LEVANT 1 and LEVANT 2 trials, including the LEVANT 2 Continued
Access cohort. This independent review confirmed through
adjudication that zero deaths were determined to be related to
paclitaxel. Moreover, no clustering or pattern of death in any
cardiovascular or non-cardiovascular categories was observed, which
would have indicated a causal relationship between paclitaxel and
death.
"The published patient-level analysis from Syntactx provides
important information that health care providers can use to make an
informed decision on the use of paclitaxel devices until additional
long-term data are available," said J.D. Meler, MD, vice president
of Medical and Clinical Affairs for BD's Peripheral Intervention
business. "Patient safety is our top priority, and BD remains
committed to improving the quality of life of patients with
PAD."
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. For more information on
BD, please visit bd.com.
Contacts:
Sandra
Moskowitz
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
201.847.5976
|
201.847.5378
|
Sandra.Moskowitz@bd.com
|
Monique_Dolecki@bd.com
|
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SOURCE BD (Becton, Dickinson and Company)