Neuromodulation Platform Receives CE Marking for Use with 3-Tesla MRI

An implantable Spinal Cord Simulation (SCS) platform intended for the treatment of chronic pain has received CE marking (Conformité Européenne) approval for expanded MR-conditional (Magnetic Resonance) labeling.

The CE marking will provide patients already receiving HF10 (High-Frequency, 10 kHz) SCS treatment with access to Magnetic Resonance Imaging (MRI) scans.

All versions of the 5-year-old SCS system, produced by Nevro (Menlo Park, CA, USA), can now be marketed in Europe and Australia, and anywhere the system is sold, for use with 1.5 Tesla and 3.0 Tesla MRI scans of the head and extremities. This is the first implantable SCS system to receive 3-Tesla compatibility.

The Senza SCS system delivers electrical pulses by means of small electrodes implanted near the spinal cord and connected to a battery-powered generator also implanted under the skin.

According to Michael DeMane, Chairman and Chief Executive Officer of Nevro, “We are pleased to offer even more imaging options for our patients. Nevro is a company that is continually looking to advance the SCS space, and this expanded MR-conditional labeling highlights our ongoing commitment to innovation.”

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