Medtronic has received FDA approval of its expanded MRI (magnetic resonance imaging) labeling for Medtronic Percept PC and Percept RC, as well as Medtronic Activa PC, RC and SC. That means that the implantable device, which is approved to treat Parkinson’s disease, essential tremor, dystonia, obsessive-compulsive disorder(OCD), and epilepsy, can be remain active during an MRI scan.
The MRI labeling approval, which the company said is exclusive to Medtronic Deep Brain Stimulation (DBS) systems, allows additional active scan time for scans below specified B1+rms limits, which is an RF exposure metric that measures how long a patient can safely remain in an MRI. Medtronic said it was the first medical device maker in the U.S. to offer full-body MR Conditional DBS systems for patients to have safe scans anywhere on the body under specific conditions.
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“We know that nearly 70 percent of all DBS-eligible patients are estimated to require an MRI as part of their essential care1,” said Ashwini Sharan, chief medical officer, Medtronic Neuromodulation, which is part of the Medtronic Neuroscience Portfolio. “Only Medtronic DBS systems can continue therapy ON in bipolar mode, under certain conditions, while a patient is having an MRI scan2-4. The updated labeling to remove the 30-minute active scan restriction, along with the Medtronic exclusive 3T MRI capability, provides patients with truly uncomplicated MRI access.”
“Patients with movement disorders have debilitating tremors that often impact their ability to physically engage in everyday moments, as well as medical treatments that require stillness like an MRI,” said Amaza Reitmeier, vice president and general manager of Medtronic Brain Modulation within the Neuromodulation business. “This updated labeling is another example of our unwavering commitment to enabling personalized patient care, with the goal of many more patient lives transformed with DBS therapy.”
The new approval arrives shortly after Medtronic said it became the first and only company to receive FDA approval to offer DBS surgery while a patient is asleep (under general anesthesia) or awake.
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