Medtronic wins CE Mark for Intellis SCS, PNS systems

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Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its Intellis spinal cord stimulation and peripheral nerve stimulation systems designed to treat chronic pain.

The Fridley, Minn.-based company touted the Intellis as the world’s smallest fully implantable SCS neurostim. The newly-cleared system includes improved battery performance and is managed through the use of a Samsung Galaxy Tab S2 tablet.

“Medtronic’s goal is to simplify treatment and improve the patient experience with personalized therapy that provides long-term pain relief and helps restore function. The launch of the Intellis platform is the culmination of 40 years of innovation and what makes Intellis such an important option is that it integrates leading-edge hardware with the Evolve workflow for SCS to help optimize pain relief,” Medtronic pain therapies division SVP Dr. Marshall Stanton said in a prepared release.

Medtronic said that the device had been implanted in its 1st patient in Europe at Sint-Niklaas, Belgium’s Pain Clinic of AZ Nikolaas Hospital, with Dr. Iris Smet performing the operation.

“Chronic pain is a complex disease that is challenging to manage. The innovations behind the Intellis platform translate into meaningful patient benefits and ease of use for physicians, which represent important advantages over other neurostimulators. I want to restore my patient’s health and improve their quality of life; the innovation behind the Intellis platform allows me to achieve that and help a broad range of patients,” Dr. Smet of AZ Nikolaas said in a prepared statement.

“Rather than rely on patient-reported data, the enhanced activity tracker of the Intellis platform provides real-time data that offers more visibility into quality of life changes. Better understanding a patient’s experience can lead to a more informed conversation that can help me maximize their pain relief and this information is easy to see and act on with the improved Samsung Galaxy tablet physician programmer,” AZ Nikolaas chair Jean-Pierre Van Buyten said in a press release.

Last week, Medtronic released six-month data from a study of its Evolut Pro transcatheter aortic valve replacement platform, touting low rates of paravalvular leaks and low rates of all-cause mortality and disabling stroke.

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