Medtronic to Present Data on Micra® Transcatheter Pacing System at Upcoming FDA Advisory Committee Meeting
January 29 2016 - 4:20PM
DUBLIN - January 29, 2016 -
Medtronic plc (NYSE: MDT) will present data on the world's smallest
pacemaker, the Micra® Transcatheter
Pacing System (TPS), at the U.S. Food and Drug Administration (FDA)
Circulatory System Devices Panel of the Medical Devices Advisory
Committee on Feb. 18, 2016, in Gaithersburg, Maryland. According to
the FDA, the committee will meet to discuss and make
recommendations on clinical trial research, post-approval study
design, and physician training requirements for leadless cardiac
pacemaker device technology.
The Micra TPS is less than one-tenth the size of
traditional pacemakers and cosmetically invisible, yet provides the
most advanced pacing technology available. It is implanted directly
into the heart and does not require the use of wires ("leads") to
deliver pacing therapy, thereby reducing potential sources of
complications seen with conventional pacing systems.
Results from the Micra TPS Global Clinical
Trial recently were published in the New England
Journal of Medicine and presented during a late-breaking
Special Report at the 2015 American Heart Association Scientific
Sessions. In the clinical data presentation, the MicraTPS was
successfully implanted in nearly all patients (99.2 percent) and
exceeded safety and effectiveness endpoints with wide margins. Most
patients (96 percent) with the Micra device experienced no major
complications; there were no (0) dislodgments, no (0) systemic
infections, and very few (0.4 percent) revisions (meaning
extraction, repositioning or replacement). Major complications
included cardiac injuries (1.6 percent), complications at the groin
site (0.7 percent) and pacing issues (0.3 percent).
The study included a comparison of Micra TPS
safety performance to a pre-defined, historical control group
consisting of more than 2,500 patients who received conventional
pacing systems. Compared to patients with conventional pacing
systems, the patients in the Micra trial were older and had more
comorbidities, yet had fewer major complications.
In the United States, the Micra TPS is an
investigational device and not yet approved for commercial use.
For more information about the FDA panel meeting,
visit:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm476987.htm.
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.
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:
Kathleen Janasz
Public Relations
+1612-743-8995
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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