Medtronic Announces Japanese Regulatory Approval for the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon
(Thomson Reuters ONE) -
Clinically-Proven, Durable, Consistent, and Safe Market-Leading DCB Poised to
Improve Outcomes for PAD Patients in Japan
DUBLIN - September 8, 2017 - Medtronic plc (NYSE: MDT) today announced that the
IN.PACT(TM)Admiral(TM) Drug-Coated Balloon (DCB) received approval from the
Japanese Ministry of Health, Labour 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).
Before Medtronic can begin commercialization, it must partner with Japanese MHLW
to gain reimbursement to ensure broader access to this innovative and
clinically-proven therapy.
"The IN.PACT Admiral DCB has demonstrated superior one-year clinical outcomes in
Japan and across Medtronic IN.PACT SFA clinical trials, providing patients with
an improved restoration of blood flow and reduced need for additional
revascularization compared to plain balloon angioplasty, a current standard of
care," said Hiroyoshi Yokoi, M.D., at Fukuoka Sannou Hospital, Japan. "In the
IN.PACT SFA Japan Trial, the DCB demonstrated superior patency and lower
reintervention rates. I look forward to treating PAD patients in Japan with this
durable, consistent, and safe DCB technology."
The MHLW granted approval for the IN.PACT Admiral DCB based on the robust
clinical data from the IN.PACT SFA Japan Trial (MDT-2113 SFA Japan Trial) led by
Osamu Iida, M.D. of Kansai Rosai Hospital, Japan and Dr. Yokoi.
The study enrolled 100 patients across 11 sites in Japan and randomized
treatment to either DCB (n=68) or plain balloon angioplasty (PTA) (n=32). The
results were consistent with one-year findings from the pivotal IN.PACT SFA
Trial, showing a consistently 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 demonstrated 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.
"Medtronic has long been committed to providing life-saving therapies to
the more than 200 million patients suffering from PAD worldwide," said Mark
Pacyna, vice president and general manager of the Peripheral business in the
Medtronic Cardiac & Vascular Group. "IN.PACT Admiral was launched more than
seven years ago in Europe. Now, with more than 200,000 patients treated, we are
excited to bring IN.PACT Admiral DCB to patients in Japan."
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 prevent artery narrowing by
minimizing scar tissue formation.
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-
Contacts:
Krystin Hayward Leong
Public Relations
+1-508-261-6512
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
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Datum: 08.09.2017 - 13:00 Uhr
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