FRANKLIN LAKES, N.J.,
June 20, 2019 /PRNewswire/ -- BD
(Becton, Dickinson and Company) (NYSE: BDX), a leading global
medical technology company, today issued the following statement
following the U.S. Food and Drug Administration (FDA) Circulatory
System Devices Panel of the Medical Devices Advisory Committee
meeting related to the potential increase in mortality associated
with the use of paclitaxel-coated devices in patients with
peripheral arterial disease (PAD) in the superficial
femoropopliteal artery (SFA):
The panel discussed the benefits of paclitaxel-coated devices
relative to the potential risks and noted strong evidence of
benefit and recommended additional efforts to evaluate long-term
safety. Additionally, BD presented its own data confirming that the
benefits outweigh the risks for LUTONIX® Drug-Coated
Balloons (DCBs) in SFA. Over the past several months, BD has been
working diligently to obtain all available patient follow up data
and collaborating with FDA, professional clinical organizations and
industry to investigate the important issue of DCB safety. BD
continues to stand behind the safety of its LUTONIX®
DCBs and is committed to improving the quality of life for patients
with PAD. BD will continue to collaborate with FDA, industry and
professional organizations to collect and analyze data for the
benefit of patients. To ensure patients with PAD continue to
receive the best care possible, BD will continue to ensure
physicians and patients have access to BD's broad range of
treatment options for this serious disease.
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 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 health care. For more information on BD, please visit
bd.com.
Contacts:
|
|
|
|
Troy
Kirkpatrick
|
Monique N.
Dolecki
|
BD Public
Relations
|
BD Investor
Relations
|
858.617.2361
|
201.847.5378
|
troy.kirkpatrick@bd.com
|
Monique_Dolecki@bd.com
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/bd-statement-on-fda-circulatory-system-devices-panel-regarding-paclitaxel-coated-devices-300872436.html
SOURCE BD (Becton, Dickinson and Company)