Medtronic Announces Consent Decree with FDA for the Synchromed Drug Infusion System and the Neuromodulation Quality System
April 27 2015 - 3:33PM
Agreement Provides
a Path to Resolution with Continued Patient Access
DUBLIN - April 27, 2015 -
Medtronic plc (NYSE: MDT) announced today that it has reached
agreement on the terms of a consent decree with the U.S. Food and
Drug Administration (FDA) specific to the company's SynchroMed®
drug infusion system and the Neuromodulation quality system. The
agreement is subject to approval by the U.S. District Court for the
District of Minnesota. Medtronic will be contacting physicians to
ensure they have information about the agreement and the steps the
company will be taking to continue to provide access to the
SynchroMed drug infusion system.
The agreement between the FDA and Medtronic
imposes certain restrictions on the company and outlines the steps
it must take to address the FDA's expectations. The company's
efforts are focused on the implementation of design changes to the
SynchroMed drug infusion pump to address issues the company has
previously communicated, and on enhancing the Neuromodulation
quality system. The agreement also includes a defined process by
which Medtronic can continue to provide physicians with access to
the SynchroMed drug infusion system for patients.
The agreement does not require the retrieval of
any Medtronic products. With this announcement there is no new
information to share about the safety and performance of the
SynchroMed drug infusion system. Patients with the SynchroMed drug
infusion system do not need to change their current course of
therapy, have the pump removed, or take any other action as a
result of this agreement. This action is not related to
Medtronic insulin pumps for diabetes. Additionally, the consent
decree does not include any Medtronic businesses other than
Neuromodulation. Medtronic does regularly communicate information
on the performance of its products and new product safety
information to physicians when available and will continue to
do so in the future.
"We are committed to the highest level of quality,
and have pursued significant efforts in recent years to enhance the
performance of the pump and to address the FDA's expectations,"
said Tom Tefft, senior vice president and president of
Neuromodulation, which is part of the Restorative Therapies Group
at Medtronic. "We are confident that our efforts to date will
contribute to the timely and thorough completion of these
activities while preserving access to this important therapy in the
interest of patients, their caregivers and physicians."
Medtronic's SynchroMed drug infusion system is
used primarily to treat chronic, intractable pain, severe
spasticity and cancer. The SynchroMed drug infusion system
delivers medication through a catheter directly to the intrathecal
space surrounding the spinal cord. Medtronic's intrathecal drug
delivery system is an important treatment option for patients who
have not had success with other therapies or who experience
intolerable side effects with oral medications.
"We take our responsibility to ensure continued
support for clinicians and their patients who rely on this
important treatment option very seriously, and we are committed to
working collaboratively with the FDA to address their expectations
as quickly as possible," said Julie Foster, general manager and
vice president, of Pain Stimulation and Targeted Drug Delivery in
the Neuromodulation business at Medtronic.
Additional information regarding the consent
decree is available at http://www.facts.synchromed.com.
Medtronic's Leadership in
Neuromodulation
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 neurostimulation and
implantable, targeted drug delivery systems for the management of
chronic pain, common movement disorders, spasticity and urologic
and gastrointestinal disorders.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is the global leader in medical technology - alleviating
pain, restoring health, and extending life for millions of people
around the world.
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:
Cindy Resman
Public Relations
+1-763-505-0291
Donna Marquard
Public Relations
+1-763-526-6248
Jeff Warren
Investor Relations
+1-763-505-2696
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
HUG#1915493
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2023 to Apr 2024