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Medtronic Announces Expansion of MR-Conditional Products with U.S. Launch of Advisa SR MRI(TM) SureScan® Pacing System

Medtronic, Inc.

Single-Chamber Pacemaker Allows for Full-Body MRI Scans Without Positioning Restrictions

DUBLIN- June 25, 2015 - Medtronic plc (NYSE: MDT), today announced the U.S. Food and Drug Administration (FDA) approval and commercial launch of the Advisa SR MRI(TM) SureScan® single-chamber pacemaker with the 5076 MRI lead, which allows for magnetic resonance imaging (MRI) scans positioned on any region of the body without restrictions. The new system includes the Advisa SR MRI pacemaker and a SureScan lead, which must be used together to be considered MR-conditional.

MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound, or CT scan, and without exposing patients to ionizing radiation. MRI is critical for the early detection, diagnosis and treatment of many diseases, including strokes, cancer, Alzheimer's disease, and muscle, bone and back pain - all of which are prevalent among older adults.

It is estimated that 50-75 percent of patients with implantable cardiac devices will need an MRI scan over the lifetime of their device.1 Until the approval of MR-conditional pacemakers, patients with implanted devices were typically denied access to MRI procedures because of the potential for harmful interaction between the device and the MRI scanner.

"MRI is a vital diagnostic tool that was not available to pacemaker patients before Medtronic released the world's first MR-conditional pacing system in 2008," said Brian Urke, vice president and general manager of the bradycardia business at Medtronic. "Through our work with clinicians, Medtronic MR-conditional pacing systems have been evaluated in four clinical studies with more than 3,600 patients, and today we offer the most extensive portfolio of MR-conditional pacing devices and leads available in the U.S."

In addition to delivering single chamber pacing with the same SureScan® technology used in other Medtronic cardiac devices, the new Advisa SR MRI(TM) pacemaker has improved diagnostic information and storage, and a 35 percent improvement2 in battery longevity (when compared to the Adapta® single chamber pacing system).

The Advisa single chamber pacemaker is the latest addition to a growing number of Medtronic devices that are designed for MRI access including the Advisa DR MRI® and Revo MRI®  dual chamber SureScan  pacing systems, the Reveal LINQ®Insertable Cardiac Monitoring (ICM) system, SureScan neurostimulation systems and the SynchroMed® II programmable drug infusion system which are available worldwide.

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 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.

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1  Kalin R and Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE 2005;28:326-328.
2 Rome, Sarah. Advisa SR MRI SureScan Longevity Calculation. February 2015. Medtronic Data On File. 

 

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