FRANKLIN LAKES, N.J.,
March 14, 2019 /PRNewswire/
-- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading
global medical technology company, today announced the U.S. Food
and Drug Administration has granted premarket approval for the
Venovo™ venous stent, the first stent indicated to treat
iliofemoral venous occlusive disease, which is obstructed or
narrowed blood flow specific to the iliac and femoral veins located
near the groin.
The Venovo™ venous stent is a flexible nitinol stent
specifically designed to reopen blocked iliac and femoral veins in
order to maintain adequate blood flow. The Venovo™ venous stent is
designed with a balance of radial strength, compression resistance
and flexibility needed for the treatment of symptomatic
post-thrombotic and non-thrombotic iliofemoral lesions.
Additionally, the broad stent sizing allows clinicians to treat
large diameter veins and long lesion lengths.
"The unique attributes of the Venovo stent make it particularly
well-suited to treat iliofemoral occlusive disease," said Dr.
Michael Dake, University of Arizona and the principal
investigator for the Venovo IDE trial. "Most importantly, it is
purpose-built for application in veins, and engineered to address
the special challenges of venous lesions that are very different
than those posed by arterial narrowing."
Iliofemoral venous occlusive disease occurs when there is
impaired blood flow in the iliofemoral vein caused by acute or
chronic deep-vein thrombosis, post-thrombotic syndrome, iliofemoral
vein compression including May-Thurner Syndrome or a combination of
these diseases.1 Symptoms include swelling of the
legs, pain when standing, skin discoloration and
ulcers.2
One-year results from the prospective, multicenter single-arm
VERNACULAR trial involving 170 subjects demonstrated the safety and
effectiveness of the Venovo™ venous stent for the treatment of
symptomatic iliofemoral venous outflow obstruction. The clinical
findings showed a weighted primary patency rate of 88.3 percent,
with a 96.9 percent patency rate in non-thrombotic lesions and an
81.3 percent patency rate in post-thrombotic lesions at 12 months,
exceeding the performance goal of 74 percent. In addition, patients
treated with the Venovo™ venous stent reported a statistically
significant reduction in pain symptoms and improvement in quality
of life (assessed by CIVIQ-20) at 12 months from baseline. The
Venovo™ venous stent was also deployed successfully to
the target lesion and showed adequate coverage in all cases, and
there were no fractures seen at 12 months.
"The FDA premarket approval of the Venovo venous stent
represents a significant advance for interventionalists treating
iliofemoral venous occlusive disease, an underrecognized
condition," said Steve Williamson,
worldwide president of Peripheral Intervention at BD. "We designed
the Venovo venous stent in collaboration with clinicians to enable
them to treat both post-thrombotic and non-thrombotic lesions.
Clinicians will now have access to the broadest range of stent
sizes in the U.S. for these difficult-to-treat lesions."
The Venovo™ venous stent is commercially available in the
U.S., Europe, Argentina, Australia, Brazil, Egypt, India,
Israel, Mexico, Russia, Saudi
Arabia, Singapore and
Taiwan.
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.
- Foley T, et al. (2015). Iliofemoral Deep Vein Thrombosis,
Available online 24 November
2015.
- Al-Nouri O, Milner R. May-Thurner Syndrome, Vascular Disease
Management 2011; 8(3).
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)