Medtronic TYRX(TM) Neuro Absorbable Antibacterial Envelope now Available for Use with Implantable Neurostimulators
October 08 2015 - 1:00PM
DUBLIN - October 8, 2015 -
Medtronic plc (NYSE: MDT) today announced the first implants of the
TYRX(TM) Absorbable Antibacterial Envelope with Medtronic Deep
Brain Stimulation (DBS) systems. The implants were conducted by
Francisco Ponce, M.D., director, Barrow Center for Neuromodulation,
at the Barrow Neurological Institute in Phoenix. Medtronic recently
received FDA clearance for the TYRX Neuro Absorbable Antibacterial
Envelope for use with implantable neurostimulators (INS), and the
product is now commercially available across the United States as
an option for use with all DBS systems. In the coming months,
Medtronic also plans to make the TYRX Absorbable Antibacterial
Envelope available as an option for use with implantable
neurostimulators to treat chronic pain and bladder and bowel
control disorders.
The TYRX Absorbable Antibacterial Envelope is a
mesh envelope that securely holds an INS or cardiac implantable
electronic device (CIED). It is designed to stabilize the device
after implantation while releasing two antimicrobial agents,
minocycline and rifampin, over a minimum of seven days to help
prevent surgical-site infections, which are associated with
substantial morbidity, mortality and cost.
"The TYRX Neuro Absorbable Antibacterial Envelope
is a much needed and long awaited solution to the risk of infection
related to implantable neurostimulators. It is going to be the
standard of care in my practice," said Dr. Ponce. "I am excited
about this technology and the potential clinical and economic
benefits it may offer our patients, our practice, and the
healthcare system."
The TYRX Absorbable Antibacterial Envelope is
fully absorbed by the body approximately nine weeks after
implantation. The TYRX Absorbable Antibacterial Envelope is
FDA-cleared for use with CIEDs (pacemakers, implantable
cardioverter-defibrillators, and cardiac resynchronization therapy
devices), and INS systems (deep brain stimulators, sacral nerve
stimulators, spinal cord stimulators and vagus nerve stimulators),
and has received CE Mark for use with CIEDs. Medtronic acquired
U.S.-based TYRX in January 2014.
"Medtronic is committed to providing technologies
that improve patient outcomes," said Lothar Krinke, vice president
and general manager of the Brain Modulation business at Medtronic.
"Reducing the risk of infection is very important as patients and
their physicians consider DBS as a treatment option."
"Extensive data has been collected on the clinical
efficacy and economic value of the TYRX antibacterial envelope with
implanted cardiac devices, and we are now pleased the envelope can
be used for patients receiving neuromodulation devices, including
those for deep brain stimulation," said Rebecca Seidel, general
manager of the Infection Control business, part of the Cardiac
Rhythm and Heart Failure division at Medtronic.
Medtronic developed and leads the field of
neuromodulation, the targeted and regulated delivery of electrical
pulses and pharmaceuticals to specific sites in the nervous system.
The company's Neuromodulation business includes medical systems for
the management of chronic pain, movement disorders, severe
spasticity and urologic and gastrointestinal disorders.
About Medtronic DBS
Therapy
Medtronic DBS Therapy is currently approved in
many locations around the world, including Europe and the United
States, for the treatment of the disabling symptoms of essential
tremor, advanced Parkinson's disease, and chronic intractable
primary dystonia, for which approval in the United States is under
a Humanitarian Device Exemption (HDE). Medtronic DBS Therapy is
also approved for the treatment of severe, treatment-resistant
obsessive-compulsive disorder in the European Union and Australia,
and in the United States under an HDE. Additionally, the therapy is
approved to treat medically refractory epilepsy in regions
including Europe, Australia, Canada, and several countries within
Latin America and Asia. More than 135,000 people have received
Medtronic DBS Therapy since it was first introduced more than 25
years ago.
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 more than 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:
Tracy McNulty
Public Relations
+1-763-526-2492
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
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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
HUG#1957204
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