Medtronic Gains Expanded MRI Labeling for DBS Systems

Medtronic has gained U.S. Food and Drug Administration (FDA) approval of expanded MRI labeling for its Percept PC and Percept RC deep brain stimulation (DBS) devices, as well as Activa PC, RC, and SC.
 
The labeling approval permits further active scan time for scans below specified B1+rms limits, growing options for diagnostics and functional assessments. Medtronic said it’s the first medical device company in the U.S. to have full-body MR conditional DBS systems for patients to have safe scans anywhere on the body, under specific conditions.
 
“We know that nearly 70 percent of all DBS-eligible patients are estimated to require an MRI as part of their essential care,” said Ashwini Sharan, chief medical officer, of Medtronic Neuromodulation. “Only Medtronic DBS systems can continue therapy ON in bipolar mode, under certain conditions, while a patient is having an MRI scan. 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.”
 
Earlier this month, the company received FDA approval for Asleep deep brain stimulation (DBS) surgery for patients with Parkinson’s and patients with essential tremor.