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Medtronic SureScan Neurostimulators Cleared by FDA for Full-Body MRI

Medtronic Restore Sensor MRI www.implantable-device.comFollowing Medtronic’s announcement in February of this year that it had introduced in Europe the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions, the Company announced today that FDA has approved the system for use in the US.  Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or eliminate the hazards produced by the MRI environment. The devices also include a proprietary SureScan programming feature, which sets the device into an appropriate mode for the MRI environment.

The press release states:

“With the first U.S. implants of its new RestoreSensor® SureScan® MRI neurostimulation systems, Medtronic, Inc. (NYSE: MDT) is introducing the first and only implantable neurostimulation (also known as spinal cord stimulation, or SCS) systems for use in the treatment of chronic, intractable back and/or limb pain that are approved by the U.S. Food and Drug Administration (FDA) for conditionally safe* full-body Magnetic Resonance Imaging (MRI) under specific conditions.

MRI scans have become a diagnostic standard of care, allowing physicians to detect a wide range of health conditions by viewing highly detailed images of internal organs, blood vessels, muscle, joints, tumors, areas of infection and other areas of the body by using strong magnetic fields and radio frequency pulses to create images of structures inside the body. As advancements in technology have increased accuracy, effectiveness and patient comfort, MRI use has grown dramatically in recent years. Worldwide, it is estimated that 60 million MRI procedures are performed each year.1 In the United States, the number of scans has nearly doubled in the past decade, with 32 million scans – more than one MRI per second — performed in 2011.2

Until now, SCS patients referred for a body MRI were denied a scan due to concerns about the system being affected by the large magnetic fields and radio frequency (RF) energy involved in MRI. Medtronic’s neurostimulation systems with SureScan MRI technology and Vectris® SureScan® MRI percutaneous leads are specially designed with enhancements to reduce or eliminate the hazards produced by the MRI environment. The systems also include a proprietary SureScan feature, which sets the neurostimulator into an appropriate mode for the MRI environment, enabling the radiology departments to easily and conveniently confirm a patient’s implantable system is safe for MRI scanning.

Among the first physicians to implant these new systems are neurosurgeon Ali Rezai, M.D., professor and director of the Center for Neuromodulation and Functional Neurosurgery at The Ohio State University Wexner Medical Center in Columbus, Ohio, and president of both the North American Neuromodulation Society and Congress of Neurological Surgeons; David L. Caraway, M.D., Ph.D., medical director for St. Mary’s Pain Relief Center in Huntington, W.Va., and a member of the board of directors for the North American Neuromodulation Society and executive vice president, American Society of Interventional Pain Physicians; and Mehul J. Desai, M.D., M.P.H., director, spine, pain medicine and research at Metro Orthopedics and Sports Therapy (MOST) in Silver Spring, Md.

“The ability to safely perform MRI scans after a spinal cord stimulator implant (SCS) is an important advance and a major benefit for our patients,” said Dr. Rezai. “In today’s medical practice, MRI examinations are necessary and routinely performed for diagnosis and clinical care. It is very likely that a patient with chronic pain, spinal disease, neurological and orthopedic disorders will require an MRI scan. However, until now, this was not feasible with SCS implants. I am happy that we will now be able to offer MRI scans for our patients.”

The RestoreSensor SureScan MRI neurostimulation system is one of a portfolio of new Medtronic neurostimulation systems enhanced with this technology and using Vectris® SureScan® MRI leads, which include: PrimeAdvanced® SureScan MRI, RestoreAdvanced® SureScan MRI, and RestoreUltra® SureScan MRI. The systems received FDA approval in March 2013 and Conformité Européenne (CE) Mark approval in January 2013.

“The approval of Medtronic’s SureScan neurostimulation systems means patients finding relief from their chronic pain with neurostimulation therapy can feel confident knowing they have access to an important diagnostic tool without compromising their healthcare,” said Julie Foster, general manager and vice president, Pain Stimulation and Targeted Drug Delivery in the Neuromodulation business of Medtronic, Inc. “This latest innovation is yet another example of our ongoing commitment to provide clinicians with safe, effective solutions to meet the needs of their patients.”

Medtronic SureScan neurostimulation systems with Vectris SureScan percutaneous MRI leads for chronic pain are the latest additions to a growing number of existing Medtronic devices that are designed for MRI access. These include the Medtronic SynchroMed® II programmable drug infusion system and Medtronic SureScan® pacing systems, which are available worldwide.”

 
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