Medtronic has received the US Food and Drug Administration (FDA) approval of its expanded magnetic resonance imaging (MRI) labelling for its deep brain stimulation (DBS) systems.
The US FDA has approved expanded MRI labelling for Medtronic Percept PC and Percept RC, as well as Medtronic Activa PC, RC and SC.
The MRI labelling approval, which applies exclusively to Medtronic DBS systems, permits extended active scan time for scans within specified B1+rms limits. The approval enhances diagnostic and functional assessment options.
Medtronic is claimed to be the first in the US to provide full-body MR Conditional DBS systems that enable patients to undergo scans anywhere on the body under specific conditions safely.
Medtronic Neuromodulation chief medical officer Ashwini Sharan said: “We know that nearly 70% of all DBS-eligible patients are estimated to require an MRI as part of their essential care.
“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.”
The approval represents another milestone for the company’s DBS systems. Last week, Medtronic received FDA approval for asleep DBS procedures for people with Parkinson’s and people with essential tremors.
DBS involves a surgically implanted device like a cardiac pacemaker. Medtronic Percept neurostimulators deliver electrical signals through fine wires to specific brain regions impacted by severe neurological disorders.
The Medtronic Percept family of neurostimulators is the first and only DBS system featuring sensing, directionality, and advanced programming capabilities, said the company.
With BrainSense technology, Medtronic’s DBS system captures and records brain signals, providing healthcare providers with crucial data and insights to customise therapy as per patient’s needs.
In January this year, the healthcare technology company secured FDA approval for its Percept RC DBS system. Percept RC is said to be the smallest and thinnest dual channel‡ neurostimulator available for DBS.
