The FDA approved expanded labeling for the Medtronic Percept PC and RC, as well as the Activa PC, RC and SC systems. This labeling approval, exclusive to Medtronic DBS systems, allows for additional active scan time for scans below specified B1+rms limits. That offers an increase in the available options for diagnostic and functional assessments.
According to a news release, Medtronic was the first medical device company in the U.S. to offer full-body MR conditional DBS systems. Patients using the company’s DBS technology can get safe scans anywhere on the body under specific conditions.
This approval marks another milestone for the company’s DBS systems. Just last week, it picked up an FDA nod for asleep DBS procedures.
Amaza Reitmeier, VP and GM, Brain Modulation within the Neuromodulation business at Medtronic, said patients with movement disorders have tremors that often impact their ability to physically engage in everyday moments. Those tremors also affect medical treatments that require stillness, like MRI, Reitmeier said. The medtech giant believes this approval expands personalized care and helps transform more patient lives with DBS therapy.
“We know that nearly 70 percent of all DBS-eligible patients are estimated to require an MRI as part of their essential care,” said Dr. 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.”
Medical Design & Outsourcing: Expect another big deep brain stimulation tech advance from Medtronic soon — Adaptive DBS
