Medtronic IN.PACT(TM) Admiral(TM) Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions
April 23 2018 - 10:00AM
New Indication
Expands DCB Treatment for Patients with SFA Lesions Up to
360mm
DUBLIN - April 23, 2018 -
Medtronic plc (NYSE: MDT) today announced that it has received U.S.
Food and Drug Administration (FDA) approval for the IN.PACT(TM)
Admiral(TM) Drug-Coated Balloon (DCB) to treat long superficial
femoral artery (SFA) lesions up to 360mm in patients with
peripheral artery disease (PAD).
Approval was based on clinical data from the
complex lesion imaging cohorts of the IN.PACT Global Study,
including long lesion, in-stent restenosis, and chronic total
occlusion (CTO) groups with lesion lengths >180mm. Across these
groups, a total of 227 subjects with mean lesion lengths of 28.7 ±
7.1 cm were analyzed. Data showed a one-year patency rate of 89.1
percent by Kaplan Meier estimate at day 360, and a
clinically-driven target revascularization (CD-TLR) rate of 7.1
percent.
"Data from the IN.PACT Global Study demonstrate
that IN.PACT Admiral DCB is a safe and effective treatment option
in real-world patients with lesions beyond 180 mm, frequently
comprised of in-stent restenosis and chronic total occlusions,"
said Daniel Clair, M.D., chair of the Department of Surgery for
University of South Carolina (USC) and the Palmetto Health-USC
Medical Group. "More specifically, these results show maintenance
of strong clinical outcomes, including a high primary patency rate
and limited need for reintervention in patients exhibiting these
complex, long lesions - among the most prevalent cases we see. The
FDA's approval of this expanded indication now offers U.S.
physicians a clinically-proven endovascular therapy to address this
critical patient need."
PAD is a serious, chronic condition that affects
more than 200 million people worldwide.1 In PAD,
arteries in the legs become narrowed or blocked by
plaque. This narrowing of the blood vessel reduces blood flow
to the leg, which can result in severe pain and limit physical
mobility.2 Complex
lesions, including those over 150mm, remain a significant treatment
challenge for physicians.
"In conversations with physicians, a key clinical
challenge raised is the ability to provide a sustainable treatment
option for longer length, complex lesions. With this approval,
IN.PACT Admiral is now indicated to treat the longest lesions of
any commercially-available DCB or peripheral stent in the
U.S., providing physicians with additional confidence in using this
DCB as part of their treatment algorithm," said Mark Pacyna, vice
president and general manager of the Peripheral business, which is
part of the Aortic & Peripheral Vascular division at Medtronic.
"In partnership with the clinical community, we look forward to
continued collaboration as we work to address additional treatment
challenges in PAD with this device."
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. It was the first DCB to have received
approval by the U.S. Food and Drug Administration (FDA) for the
treatment of in-stent restenosis. The DCB's primary mode of action
is physical dilatation of the vessel lumen by PTA, and the proven
paclitaxel drug, with a unique dose and excipient, is intended to
prevent artery narrowing by minimizing scar tissue formation.
IN.PACT Admiral received the CE (Conformité Européene) Mark in March 2009 to treat PAD
and was approved by the FDA 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 200,000 patients have been
treated with IN.PACT Admiral. It is the only DCB to have published
three-year data and the first to have presented four-year data from
a pivotal randomized trial.
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 of the highest quality 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 84,000 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-
1 Fowkes,
F. G., et al. (2013). Lancet 382(9901): 1329-1340.
2 Roberts,
D., et al. (2014). Catheter Cardiovasc Interv 84(2): 236-244.
Contacts:
Julia Baron
Public Relations
+1-858-692-2001
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2023 to Apr 2024