Medtronic wins FDA nod for Intellis SCS, launches in US

Monday, September 18, 2017

Source: Mass Device

Medtronic (NYSE:MDT) said today it won FDA approval for its Intellis implantable spinal cord stimulation system and launched it in the US.

The Fridley, Minn.-based company touted the newly revised system as the world’s smallest, and said that the new unit was designed to improve battery performance and standardize guidance and balancing of high-dose and low-dose therapy settings.

“Drawing upon our 40-year legacy in SCS, the launch of the Intellis platform isn’t just about a new device, but about combining cutting edge hardware with optimal therapy through the Evolve workflow to enable personalized, long-term pain relief. Medtronic is committed to addressing patient needs, so the Intellis platform was designed based on what is most important to patients and physicians. We considered the entire patient journey – starting with the primary goal of optimal pain relief and access to important diagnostic tools, like MRI, to ease of use with simplified programming, faster recharge and a smaller implant,” Medtronic pain therapies division prez Dr. Marshall Stanton said in a press release.

Medtronic said that the device is designed to interface with a Samsung Galaxy Tab S2 tablet interface to allow physicians to actively monitor and make modifications to the unit to meet patient needs.

“Chronic pain is challenging to manage. Having real-time data can provide more information about patients’ quality of life changes. This platform represents a welcome new option for managing some kinds of chronic pain. New non-opioid treatment options are important given the national crisis related to opioid abuse,” Dr. Lance Roy of Duke University Medical Center, which implanted 1 of the 1st patients with the device, said in a prepared statement.

Last week, Medtronic invested $40 million in Mazor Robotics (NSDQ:MZOR) in a deal that gave the medtech giant exclusive global distribution rights for the Mazor X robot-assisted surgery device.

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