Medtronic
Medtronic has received U.S. Food and Drug Administration (FDA) approval of its expanded magnetic resonance imaging (MRI) labelling for Medtronic Percept PC and Percept RC, as well as Medtronic Activa PC, RC and SC.
The MRI labelling approval, exclusive to Medtronic Deep Brain Stimulation (DBS) systems according to the company, allows additional active scan time for scans below specified B1+rms limits, increasing the options available for diagnostic and functional assessments. Medtronic says it was the first medical device innovator 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.
“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, 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 scan. The updated labelling 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 labelling is another example of our unwavering commitment to enabling personalised patient care, with the goal of many more patient lives transformed with DBS therapy.”
