Medtronic Receives FDA Approval for IN.PACT Admiral DCB 150 mm Lengths
July 13 2016 - 9:00AM
Expanded Treatment
Options for Patients with Longer SFA Lesions with Best-In-Class
Drug-Coated Balloon Technology Now Available
DUBLIN - July 13, 2016 -
Medtronic plc (NYSE: MDT) has received U.S. Food and Drug
Administration (FDA) approval for the IN.PACT(TM) Admiral(TM)
drug-coated balloon (DCB) in longer, 150 mm lengths. The new 150 mm
length balloon, available in four, five, and six mm diameters, will
provide greater treatment options for long lesions in patients with
peripheral artery disease (PAD).
"The long lesion (10-18 cm) sub-group outcomes
from the IN.PACT SFA Trial at one year demonstrated superiority
over balloon angioplasty," said John Laird, M.D., interventional
cardiologist at U.C. Davis Medical Center and co-principal
investigator for the IN.PACT SFA Trial. "The availability of the
150 mm length sizes will expand proven treatment options to more
patients."*
The IN.PACT SFA Trial, a prospective,
multi-center, randomized, controlled pivotal trial demonstrated, in
a subgroup of patients with lesions >=10 cm and <18 cm, a
clinically-driven target lesion revascularization (CD-TLR) rate of
5.3 percent for the IN.PACT Admiral DCB arm (n=79) and 32.4 percent
for the PTA arm (n=36) (p<0.001). There were no device or
procedure-related deaths, no occurrences of major target limb
amputation, and a 3.9 percent thrombosis rate in the IN.PACT
Admiral DCB arm versus 5.9 percent in the PTA arm through 12 months
(p=0.326) in this subgroup.
"The expansion of IN.PACT Admiral DCB to 150 mm
lengths demonstrates our commitment to providing meaningful
technology to improve patient outcomes in a value-based healthcare
environment," said Mark Pacyna, vice president and general manager
of the Peripheral business, which is part of the Aortic &
Peripheral Vascular division at Medtronic. "The IN.PACT Admiral
platform continues to show durable, consistent, and safe
outcomes."
About IN.PACT Admiral Drug-Coated
Balloon
The IN.PACT Admiral drug-coated balloon is a clinically-proven,
cost-effective primary endovascular therapy that enables physicians
to treat claudication and restenosis for patients with superficial
femoral artery (SFA) disease. The DCB's primary mode of action is
physical dilatation of the vessel lumen by PTA, and the proven
paclitaxel drug is intended to prevent artery narrowing by
minimizing scar tissue formation.
IN.PACT Admiral DCB received the CE (Conformité
Européene) Mark in 2009 to treat PAD and was approved by the U.S.
Food & Drug Administration in December 2014 to treat
superficial femoral and popliteal arteries. It has been studied in
more than 20 individual clinical trials demonstrating durable
safety and clinical benefits. To date, more than 150,000 patients
have been treated with IN.PACT Admiral DCB. See:
http://www.medtronic.com/dcbresults
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 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.
* Cited clinical results from
Medtronic IN.PACT Admiral DCB studies did not include the 150 mm
lengths.
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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information contained therein.
Source: Medtronic plc via Globenewswire
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