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Medtronic : Announces Commercial Launch of the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon in Japan

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08/15/2018 | 04:02pm CEST
DUBLIN - August 15, 2018Medtronic plc (NYSE:MDT) today announced full
commercial launch of the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon (DCB) in
Japan. The news follows the completion of a post-market clinical trial, which
enrolled 300 subjects.

IN.PACT Admiral received approval last year from the Japanese Ministry of
Health, Labor and Welfare
(MHLW) for the treatment of peripheral artery disease
(PAD) in the upper leg - specifically, in the thigh (superficial femoral
arteries (SFA)) and behind the knee (popliteal arteries). The MHLW also granted
reimbursement approval for the IN.PACT Admiral in December of 2017.

"In Japan, there is a significant need for new technologies to safely and
effectively treat PAD," said Tony Semedo, president, Medtronic Japan. "Earlier
this year, we presented both one- and two-year results from the IN.PACT SFA
Japan study, representing consistency in clinical data shared on IN.PACT Admiral
to-date. Now with the completion of our post-market study, we will become the
first company to bring DCB technology to Japanese physicians and their

Approval for IN.PACT Admiral in Japan was based on data from MDT-2113 (IN.PACT
SFA Japan), which enrolled 100 patients across 11 sites and randomized treatment
to either DCB (n=68) or standard percutaneous transluminal angioplasty (PTA)
(n=32). The results were consistent with one-year findings from the pivotal
IN.PACT SFA Trial, showing a low clinically-driven target lesion
revascularization (CD-TLR) rate and high patency rate.

IN.PACT Admiral SFA Japan demonstrated 93.9 percent primary patency in the DCB
group as compared to 46.9 percent in the PTA group at one year based on Kaplan-
Meier Estimate (p<0.001). Additionally, one-year results showed a CD-TLR rate of
2.9 percent for the DCB group compared to 18.8 percent in the PTA group
(p=0.012). In IN.PACT SFA Japan, major adverse events were also lower for the
DCB at one year (4.4 percent compared to 18.8 percent in the PTA group;
p=0.028), with no major target limb amputations or all-cause death in both
treatment groups.

Most recently, two-year data from IN.PACT SFA Japan were presented at the
Leipzig Interventional Course (LINC) in Leipzig, Germany. Results were also
consistent with two-year findings from the IN.PACT SFA Trial.

"We are incredibly proud to have paved the way for IN.PACT Admiral and DCB
technology in Japan," said Mark Pacyna, vice president and general manager of
the Peripheral business, which is part of the Aortic & Peripheral Vascular
division at Medtronic. "We worked closely with regulatory bodies to obtain both
product and reimbursement approvals for IN.PACT Admiral, and we have continued
to demonstrate IN.PACT Admiral's superior safety and efficacy compared to PTA in
a Japanese patient population. We look forward to bringing this proven
technology to Japan and providing physicians with the tools they need to
effectively treat PAD."

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

About the IN.PACT Admiral Drug-Coated Balloon
The IN.PACT Admiral drug-coated balloon is a clinically-proven primary
endovascular therapy. It has been approved in Japan to treat de novo and non-
stented restenotic lesions with length <=200 mm in superficial femoral and
popliteal arteries with reference vessel diameters of >=4 mm and <=7 mm. The
DCB's primary mode of action is physical dilatation of the vessel lumen by PTA,
and the proven paclitaxel drug is intended to reduce restenosis.

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

Julia Baron
Public Relations

Ryan Weispfenning
Investor Relations
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

© InPublic, source US Press Releases

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Financials ($)
Sales 2019 30 597 M
EBIT 2019 8 808 M
Net income 2019 5 032 M
Debt 2019 10 521 M
Yield 2019 2,14%
P/E ratio 2019 25,01
P/E ratio 2020 22,31
EV / Sales 2019 4,35x
EV / Sales 2020 4,08x
Capitalization 123 B
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Number of Analysts 25
Average target price 95,4 $
Spread / Average Target 4,8%
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Omar S. Ishrak Chairman & Chief Executive Officer
Mark Ploof Senior Vice President-Global Operations
Karen L. Parkhill Chief Financial Officer & Executive Vice President
Richard E. Kuntz Chief Scientific, Clinical & Regulatory Officer
Richard H. Anderson Lead Independent Director
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