Medtronic wins FDA nod for DBS clinician programmer

Medtronic (NYSE:MDT) said today it won FDA approval for its Deep Brain Stimulation clinician programmer and Activa programming application.

The Fridley, Minn.-based medtech giant said that the Activa programming application, which is designed for use with Samsung Galaxy Tab S2 tablets, is intended to streamline workflows and improve clinician programming for its Activa DBS system.

Medtronic said that the programmer will enable upgrades to Activa rechargeable implantable neurostims that will extend their lifespans to 15 years, giving patients an additional six years before they need device replacement. The newly cleared programmer will also work with the company’s Activa DBS system designed to treat medically refractory epilepsy, which it expects to launch later this year.

“After using the Medtronic clinician programmer for the first time, I am impressed with the thoughtfulness put into the user interface. Its intuitive, visual interface and task-based workflow makes daily use easier, saving me time to focus on what’s most important-my patients,” Dr. Mohammad Maarouf of Germany’s Cologne Merheim Medical Center said in a prepared statement.

Medtronic said that it expects to initiate a launch of the programmer in the US before the end of July.

“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. 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 6 extra years of therapy between surgeries, giving them even more time to do the things they love,” Medtronic brain modulation biz GM Mike Daly said in a press release

The DBS clinician programmer won CE Mark approval in the European Union in March, and a launch of the device is already underway in the region.

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