First European Patients Enroll in Medtronic International Lung Cancer Study
(Thomson Reuters ONE) -
NAVIGATE Study Assesses Impact of Minimally Invasive Technology to Aid in Early
Diagnosis and Treatment of Lung Cancer
DUBLIN - March 10, 2016 - Committed to technologies that assist in the goal of
reducing lung cancer morbidity worldwide, Medtronic (NYSE: MDT) today announced
European enrollment in the NAVIGATE clinical trial. This 2,500-patient
international study will assess the long-term impact of its superDimension(TM)
navigation system as an aid in early detection of lung cancer and subsequent
treatment.
The superDimensionsystem uses LungGPS(TM) technology, the first of its kind to
enable Electromagnetic Navigation Bronchoscopy (ENB) procedures. ENB procedures
provide a minimally invasive approach to access difficult-to-reach areas of the
lung, which can aid in the diagnosis of lung disease, can help patients avoid
surgery for benign disease and other invasive procedures like transthoracic
needle aspiration, and lead to earlier, personalized treatment - potentially
saving lives. The superDimension system has received CE Mark in Europe, 510(k)
clearance in the US and has also been approved for use in numerous international
markets.
"Early detection, diagnosis and intervention are crucial to the survival of
people living with lung cancer," said Mag. Petra Lichtenberger, Assistant to
Prof. Dr. Lamprecht at the Department of Pulmonology of Kepler University Clinic
Linz, Austria, which enrolled the first ENB patient in Europe. "Technology that
allows medical professionals to view areas of the lung that could not be
accessed before is a major advance that is changing the landscape of lung cancer
diagnosis and helping save patient lives."
Up to 75 centers around the world will enroll patients in the single-arm, multi-
center post-market observational study designed to evaluate the impact of ENB
procedures on early diagnosis and treatment. The NAVIGATE study will also
determine the success rate of physicians using the technology to obtain biopsy
samples from the surrounding lymph nodes. In addition, the study will assess the
effectiveness of physicians' placement of fiducial markers or dyes to guide
subsequent procedures to treat or remove lung tumors.
More than 22 sites have been activated to enroll patients since the study first
launched in the U.S. in April 2015. Healthcare professionals will follow
patients for 24 months.
"The NAVIGATE study represents our commitment to delivering meaningful
solutions that support the early detection and treatment of lung cancer to save
patient lives," said Vafa Jamali, president, Early Technologies business in the
Medtronic Minimally Invasive Therapies Group. "The enrollment of patients in
Europe for the NAVIGATE study is a significant milestone and an important step
to help establish ENB procedures as the gold standard for detecting lung cancer
in the earlier, more curable stages."
According to the World Health Organization, lung cancer is the number one cancer
killer in the world, accounting for 1.59 million deaths in 2012.(1 )In its early
stages, lung cancer presents few, if any, symptoms. As a result, diagnosis for
the vast majority of lung cancer patients happens in the late stages, and long-
term survival rates drastically decline. When diagnosed early, an estimated 85
percent of lung cancer cases appear at a more curable stage.(2 )Early detection
and immediate treatment dramatically increases the typical long-term survival
rate from 15 percent at five years(3 )to 88 percent at 10 years.(2)
To date nearly 100,000 ENB procedures have been performed globally at more than
600 hospitals commercially and as part of prior clinical trials.
Additional information about the NAVIGATE study and enrolling sites can be found
at clinicaltrials.gov/ct2/show/NCT02410837.
Multimedia Release
A multimedia version of this release, with video and links to graphics can be
found at: http://bit.ly/1TIeoLk.
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-
--------------------------------------------------------------------------------
1 World Health Organization. Cancer. Fact Sheet. Last updated February 2015.
www.who.int/mediacentre/factsheets/fs297/en/. Accessed January 20, 2016.
2 The International Early Lung Cancer Action Program Investigators. N Engl J
Med. 2006; 355:1763-1771.
3 Molina JR, Yang P, Cassivi SD, Schild SE, Adjei AA. Non-small cell lung
cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc.
2008;83(5):584-594.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2718421/. Accessed January 20, 2016.
Contacts:
John Jordan
Public Relations
+1-508-452-4891
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This announcement is distributed by GlobeNewswire on behalf of
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other applicable laws; and
(ii) 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: 10.03.2016 - 13:58 Uhr
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