DUBLIN, Oct. 26, 2020 /PRNewswire/ -- Medtronic plc
(NYSE:MDT), the global leader in medical technology, today
announced it has received U.S. Food and Drug Administration (FDA)
approval for the Abre™ venous self-expanding stent system. This
device is indicated for use in the iliofemoral veins in patients
with symptomatic iliofemoral venous outflow obstruction, also known
as deep venous obstruction.
Deep venous obstruction occurs when the veins in the deep venous
system become obstructed, blocked and/or compressed causing
restricted blood flow to the heart. If left untreated, patients can
experience leg discomfort and pain, limiting their mobility and
quality of life. Symptoms of the disease include leg swelling, skin
changes, leg ulcers, and pain. Severe complications can occur, such
as blood clots that migrate to the lungs (pulmonary embolism), a
clot in the leg called a deep vein thrombosis (DVT), or the
formation of fibrotic tissue or scarring caused by a chronic DVT
(post thrombotic syndrome).
The FDA approval is based on 12-month results from the ABRE
clinical study, presented at the 2020 Charing Cross Symposium. The
ABRE study assessed the safety and effectiveness of the
investigational Abre stent in 200 patients with iliofemoral venous
outflow obstruction across the spectrum of deep venous obstruction
including those with post thrombotic syndrome, non-thrombotic iliac
vein lesions (NIVL), and those who presented with an acute deep
vein thrombosis (aDVT). The study also included a challenging
patient population, 44% (88/200) of whom required stents that
extended below the inguinal ligament into the common femoral vein
(CFV). The study met its primary safety endpoint with a 2.0%
(4/200) rate of major adverse events (MAEs) within 30
days.1 The study also met its 12-month primary
effectiveness endpoint with an overall primary patency rate of
88.0% (162/184).2 Despite the challenging patient
population, no stent fractures and no stent migrations were
reported in the study.
"Patients with deep venous obstruction are often younger,
therefore it's critical to have a venous stent that is not only
safe and effective, but also strong and flexible," said
Erin Murphy, M.D., F.A.C.S., global
principal investigator for the ABRE clinical study and director of
Atrium Health Sanger Heart & Vascular Institute's Venous
and Lymphatic Program in Charlotte, North
Carolina. "With FDA approval, we now have this important
tool in our arsenal to treat patients with even the most
challenging of deep venous lesions."
A self-expanding stent system, Abre is intended for permanent
implant and utilizes an open-cell design with three off-set
connection points to enable flexibility and stability during
deployment. Abre also offers a balance of strength, flexibility,
and fatigue resistance. Based on data presented at the Leipzig
Interventional Course (LINC) 2020 annual meeting by Stephen Black, M.D., consultant and vascular
surgeon, Guy's, and St. Thomas' Hospital and Kings College in London, the Abre stent system demonstrated a
0% fracture rate in bench testing simulated out to 50
years.3
"With Abre, our goal was to create a dedicated venous stent that
combined a balance of the key characteristics necessary to treat
patients with a broad spectrum of deep venous obstruction," said
Carolyn Sleeth, vice president and
general manager of the endoVenous business, which is part of the
Cardiac and Vascular Group at Medtronic. "We are excited to bring
Abre to the U.S. market, which we believe will provide both
physicians and patients with a new option backed by clinical
evidence to treat this disease safely and effectively."
Abre received CE (Conformité Européene) Mark approval in April
of 2017 and is also intended for use in the iliofemoral veins for
treatment of symptomatic venous outflow obstruction.
In collaboration with leading clinicians, researchers, and
scientists worldwide, Medtronic offers the broadest range of
innovative medical technology for the interventional and surgical
treatment of cardiovascular disease and cardiac arrhythmias. The
company strives to offer products and services that deliver
clinical and economic value to healthcare consumers and providers
around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest
medical technology, services and solutions companies
– alleviating pain, restoring health and extending life for
millions of people around the world. Medtronic employs more than
90,000 people worldwide, serving physicians, hospitals and patients
in more than 150 countries. The company is focused on collaborating
with stakeholders around the world to take healthcare Further,
Together.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated
results.
1MAEs, as defined in the study protocol, included
all-cause death occurring post-procedure, clinically significant
pulmonary embolism, procedural major bleeding, stent thrombosis,
and stent migration. MAEs were adjudicated by a Clinical Events
Committee, except stent thrombosis and stent migration, which were
assessed by an imaging core laboratory.
2 Primary Patency was defined as meeting all of the
following criteria at 12 months post-procedure: Freedom from
occlusion or restenosis ≥50% of the stented segment of the target
lesion and freedom from clinically driven target lesion
revascularization.
3 Test data on file at Medtronic. Bench test results may
not be indicative of clinical performance.
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SOURCE Medtronic plc