Precision Plus Spinal Cord Stimulator System receives CE mark approval as MRI conditional


Boston Scientific has received CE mark approval for its Precision Plus Spinal Cord Stimulator (SCS) System. Precision Plus can now be used in patients with chronic intractable pain who need magnetic resonance imaging (MRI) head-only scans. 

According to a company release, the Precision Plus SCS System is the world’s first rechargeable SCS device. When compared to non-rechargeable SCS systems, rechargeable SCS systems may offer clinical benefits by extending therapeutic longevity and therefore avoiding frequent replacement surgeries and complications that may arise from repeated surgeries.

“As spinal cord stimulation becomes more widespread for control of severe disabling refractory pain, it is great to know that should the need arise head-only MRI scans can be safely performed in patients with the Precision Plus SCS System,” said Simon Thomson, consultant in pain medicine and neuromodulation at Basildon and Thurrock University Hospitals in the United Kingdom.

“We are pleased to announce that patients implanted with the Precision Plus SCS System will now be able to undergo MRI head scans,” said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific. “We understand the need to provide physicians the necessary options to be able to manage their patients’ care and believe this new MRI labeling will play a role for them.”

Spinal cord stimulation is a reversible therapy that manages pain through an implantable pulse generator (IPG) and thin wires called electrodes, or “leads”, that are implanted in the spinal column. The device electrically stimulates specific nerves of the spinal cord to mask the brain’s perception of specific pain signals that move up the spinal cord.