Medical tech company Medtronic has just landed FDA clearance on its Deep Brain Stimulation (DBS) Clinical Programmer and ActivaProgramming application.
"This marks a new era of innovation from the only partner with a 25-year DBS legacy, and paves the way to our vision of the future of DBS with a fully integrated system from planning to programming," said Mike Daly, vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. "Additionally, this launch serves as evidence of our dedication to the Medtronic Mission and our DBS patients, with the extension of the device longevity of the ActivaRC rechargeable neurostimulator. Now patients can benefit from six extra years of therapy between surgeries, giving them even more time to do the things they love.”
Medtronic’s DBS therapy has been on the market for 25 years. The DBS systems are surgically implanted into a patients brain to deliver electrical stimulation to precisely targeted areas of the train, according to a statement. It can be used to treat Parkinson’s disease, epilepsy, and other neurologic disorders.
The ActivaProgramming Application was designed to streamline workflows and provide actionable information to neurologists and neurosurgeons who are treating patients using Medtronic’s Activa DBS system.
The system will be able to program interactions in the implanted Medtronic Activadevices. According to a statement, the Medtronic DBS Clinician Programmer is approved to be used in conjunction with the soon to be released Medtronic Activa DBS system, which was designed to treat refractory epilepsy, as well as previously released technologies.
The latest clearance for the programmer and application comes on the heels of the product’s CE Mark in March. The US launched is expected to take place this July.
This isn’t Medtronic’s first FDA clearance this year. In March the Minneapolis, MN and Dublin, Ireland-based company got the go ahead from the agency for its Guardian Connect, a smartphone-connected standalone CGM for patients who use multiple daily injection for their insulin.