Medtronic Receives FDA Approval for 200mm & 250mm IN.PACT(TM) Admiral(TM) Drug Coated Balloons
June 15 2018 - 8:30AM
New, Extended
Balloon Lengths Enable Physicians to Efficiently Treat Long SFA
Lesions
DUBLIN - June 15, 2018 -
Medtronic plc (NYSE: MDT) today announced that it has received U.S.
Food and Drug Administration (FDA) approval for 200mm and 250mm
lengths of the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon (DCB) to
treat long superficial femoral artery (SFA) lesions in patients
with peripheral artery disease (PAD).
"As SFA disease progresses, we tend to see
patients present with longer, more complex lesions. As a result,
these lesions become incredibly challenging to treat and often
require interventions with multiple technologies to effectively
treat the entire segment," said Gary Ansel, M.D., system medical
director for Vascular Services at OhioHealth Riverside Methodist
Hospital in Columbus, Ohio. "The approval of the IN.PACT Admiral
200mm and 250mm balloons provides physicians with a solution to
treat these long, complex lesions with fewer devices, potentially
leading to shorter procedure times and reduced procedural
cost."
Complex lesions, including those over 150mm, are
commonly encountered in clinical practice and remain a significant
treatment challenge for physicians. In April of this year, IN.PACT
Admiral received approval to treat SFA lesions up to 360mm in
length. 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.
"In our IN.PACT Global Study, IN.PACT Admiral
demonstrated safety and effectiveness in real-world patients with
complex lesions, including long lesions," said Mark Pacyna, vice
president and general manager of the Peripheral business in
Medtronic's Cardiac & Vascular Group. "Our new long lesion
indication - coupled with the approval of the 200mm and 250mm
balloons -furthers our commitment to the clinical community by
equipping them with the tools and evidence needed to effectively
treat complex cases."
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 SFA disease.
It was the first DCB to receive approval by the U.S. FDA for the
treatment of in-stent restenosis and lesions up to 360mm in length.
The DCB's primary mode of action is physical dilatation of the
vessel lumen by PTA, followed by the delivery of paclitaxel. With a
unique dose and excipient, IN.PACT Admiral 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 86,000 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.
-end-
Contacts:
Julia Baron
Public Relations
+1-858-692-2001
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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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
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