|Medtronic Announces Consent Decree with FDA for the Synchromed Drug Infusion System and the Neuromodulation Quality System|
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
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.
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