Medtronic IN.PACT Admiral DEB Receives CE Mark for Treatment of AV Access In Patients with End-Stage Renal Disease
January 11 2016 - 9:00AM
IN.PACT Admiral
DEB with 40 Centimeter Catheter Enables Physicians to Maintain
Arteriovenous (AV) Access in Patients Undergoing
Hemodialysis
DUBLIN - January 11, 2016 -
Medtronic plc (NYSE:MDT), a global leader in medical technology,
services and solutions, today announced that the IN.PACT®
Admiral® drug eluting
balloon (DEB) (also known as the IN.PACT Admiral drug-coated
balloon (DCB) in non-European markets) has received CE (Conformité
Européene) Mark for arteriovenous (AV) access to help maintain
hemodialysis access in patients with end-stage renal disease.
Globally, more than 2.5 million end-stage renal
disease patients are undergoing hemodialysis, a procedure
that filters waste and removes extra fluid from the
blood when the kidneys are no longer healthy. AV access
sites are used to provide hemodialysis to patients. However,
thickening of the vessel walls and restenosis, due to repeated
access for needed dialysis, can limit the ability to use and
eventually shut down the dialysis access site. IN.PACT Admiral DEB
aids in preventing restenosis, by opening the artery and delivering
paclitaxel, an anti-proliferative agent, to the vessel wall. A new
40 centimeter catheter shaft will also be made commercially
available in Europe under the expanded indication, which is
specifically designed for AV access. In the United States, IN.PACT
Admiral DEB is approved to treat superficial femoral and popliteal
arteries.
"For patients with hemodialysis, maintaining AV
access is their lifeline to receiving the care they need to filter
waste from their system. In the past, when the access site
became stenosed, the only option was the use of a standard
percutaneous transluminal angioplasty (PTA), which can result in
the need for repeat procedures," said Konstantinos Katsanos, M.D.,
Ph.D., Guy's and St. Thomas' Hospital, London, UK. "The IN.PACT
Admiral DEB, in my experience, provides a safe and more effective
way of managing AV access by preventing vascular restenosis,
improving patency of dialysis fistulas and grafts, and
reducing the need of repeat PTA procedures."
"IN.PACT Admiral DEB, a best-in-class therapy for
the treatment of superficial femoral artery (SFA) disease, is now
indicated in Europe for the treatment of AV access, providing a
durable primary intervention that aids in extending time to
re-intervention while preserving future treatment options," said
Brian Verrier, vice president and general manager of the Peripheral
business, within the Aortic and Peripheral Vascular division at
Medtronic. "Improving lives and alleviating pain is a core piece of
Medtronic's mission, and through IN.PACT Admiral DEB, we can help
physicians treat patients with end-stage renal disease."
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 IN.PACT Admiral Drug-Coated
Balloon
The IN.PACT Admiral drug-coated balloon (DCB) is a
clinically-proven, cost-effective primary endovascular therapy that
enables physicians to treat claudication, restenosis and alleviate
pain from superficial femoral artery (SFA) disease. The DCB's
primary mode of action is physical dilatation of the vessel lumen
by percutaneous transluminal angioplasty (PTA), and the proven
paclitaxel drug is intended to prevent artery narrowing by
minimizing scar tissue formation. See how it works, click here.
IN.PACT Admiral DCB received the CE (Conformité
Européene) Mark in 2009 to treat peripheral artery disease (PAD)
and approval by the U.S. Food & Drug Administration in December
2014 to treat superficial femoral and popliteal arteries. In 2016,
the CE Mark indication was expanded for the treatment of failing
arteriovenous (AV) access in patients with end-stage renal disease
undergoing dialysis. It is the most studied drug-coated balloon,
with more than 20 individual studies demonstrating the durability,
safety and clinical benefits. To date, more than 70,000 patients
have been treated with IN.PACT Admiral DCB.
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 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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.
-end-
Contacts:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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