First Patient Enrollment in AGILITY Study
Begins Investigations of Safety and Effectiveness of BD
Vascular Covered Stent for Treatment of PAD
FRANKLIN
LAKES, N.J., March 4,
2024 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading
global medical technology company, today announced the enrollment
of the first patient in the investigational device exemption (IDE)
study, "AGILITY," which will assess the safety and effectiveness of
the BD Vascular Covered Stent for the treatment of Peripheral
Arterial Disease (PAD).
The investigational Vascular Covered Stent is a self-expanding,
low profile, polytetrafluoroethylene encapsulated nitinol implant.
It is deployed from a delivery system that provides controlled
stent release.
"When we're addressing advanced PAD, a self-expanding covered
stent can play an important role," said Dr. Sean Lyden, chairman of the Department of
Vascular Surgery at Cleveland Clinic and National Principal
Investigator of the AGILITY study. "We need a stent that can track
to the lesion, apposes the vessel wall and ultimately provides
long-term durability. We're excited to see how this technology
performs."
According to BD, the global, prospective, multi-center,
single-arm, non-randomized AGILITY clinical study will include 315
patients at up to 40 clinical study sites across the United States, Europe, Australia and New
Zealand. Follow-up for all treated patients will be
performed at various points after treatment — starting at one month
and ending at 36 months.
PAD affects more than 18 million Americans and more than 236
million people worldwide.1,2 It is a potentially
debilitating disease that can lead to increased risk of
cardiovascular complications and limb amputation. A healthy diet,
exercise and cessation of smoking can help mitigate the development
of PAD, which includes the formation of atherosclerosis and blood
clots in arteries in the legs. Minimally invasive techniques using
devices such as angioplasty balloons, drug-coated balloons,
atherectomy and covered stents can be used to increase blood flow
through the diseased areas.
"There continues to be significant unmet needs in the treatment
of PAD patients," said Tim Hug, vice
president and general manager at BD Peripheral Intervention. "We
are excited to have initiated this study and evaluate the treatment
benefits of this potentially differentiated technology. This stent
could give interventionalists an important new solution in the
fight against PAD, expand our portfolio and enable us to better
serve our customers and the patients they treat."
The first patient in the AGILITY study was enrolled at Trinity
Medical Center in Bettendorf, Iowa
by Dr. Nicolas Shammas,
Interventional Cardiologist, Cardiovascular Medicine, PLLC; Founder
and President of the Midwest Cardiovascular Research Foundation,
Davenport, Iowa; and Adjunct
Professor of Medicine, University of
Iowa.
# # #
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 more than 70,000 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 or connect with us on
LinkedIn at www.linkedin.com/company/bd1/, X (formerly Twitter)
@BDandCo or Instagram @becton_dickinson.
Contacts:
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Media:
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Investors:
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Troy Kirkpatrick
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Adam Reiffe
|
VP, Public
Relations
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Sr. Director, Investor
Relations
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858.617.2361
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201.847.6927
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troy.kirkpatrick@bd.com
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adam.reiffe@bd.com
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____________________
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1 "THE SAGE
GROUP Releases New Estimates for the United States Prevalence of
Peripheral Artery Disease (PAD) and Critical Limb," September 30,
2010,
https://www.fiercehealthcare.com/healthcare/sage-group-releases-new-estimates-for-united-states-prevalence-peripheral-artery-disease
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2
Epidemiology of Peripheral Artery Disease: Narrative Review.
(2022, July 12). National Library of Medicine. Retrieved February
21, 2024,
from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9320565/
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SOURCE BD (Becton, Dickinson
and Company)