Medtronic plc's (NYSE: MDT) Deep Brain Stimulation (DBS) Clinician Programmer and Activa Programming Application have been approved by the US Food and Drug Administration (FDA), the medical technology company announced on Wednesday.
It follows European approval in March.
The European launch is currently underway, with the US launch expected to take place before the end of July 2018.
DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas of the brain as adjunctive treatment for movement and neuropsychiatric disorders.
The Activa Programming Application was designed with the input of over 100 clinicians and is managed on the Samsung Galaxy Tab S2 tablet interface.
According to Medtronic, the new tool will enhance the clinical programming experience, streamline workflows and provide actionable information to support neurologists and neurosurgeons in their treatment of patients that use the Medtronic Activa DBS system as therapy for neurological disorders such as dystonia and Parkinson's disease.
Additionally, it will enable the service life of Activa rechargeable implantable neurostimulators to be extended to 15 years, giving patients an additional six years until their next device replacement.
The Medtronic DBS Clinician Programmer is also approved for use with Medtronic Activa DBS systems that treat medically refractory epilepsy, a therapy that will be launched in the United States later this year.
Crossject advances paediatric development of ZEPIZURE Junior for epilepsy crisis management
Creo Medical secures FDA clearance for SpydrBlade Flex in US market
Tissue Regenix secures CE and UKCA certifications for OrthoPure XT
Terumo Corporation expands stroke portfolio in EMEA with SOFIA Flow 88 catheter launch
Crossject advances ZENEO manufacturing with scalable aseptic filling module ahead of product rollout
ZYLOX Unicorn Vascular Closure Device approved in Indonesia
Mindray unveils BeneVision V Series at Euroanaesthesia 2025, advancing precision monitoring
Unicon Pharma and VRR Life Sciences partner support digital transformation in life sciences
Median Technologies submits 510(k) application for eyonis LCS lung cancer screening software