Spinal Cord Stimulator Receives CE Marking for MRI Head Scanning

A spinal cord stimulator (SCS) system has received the European CE marking for patients who require magnetic resonance imaging (MRI) head-only scans.

The Precision Plus SCS system, developed by Boston Scientific Corp. (Natick, MA, USA) is the world’s first rechargeable SCS device. This approval provides physicians with an additional diagnostic alternative for patients with chronic intractable pain.

“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 Dr. Simon Thomson FFPMRCA, consultant in pain medicine and neuromodulation at Basildon and Thurrock University Hospitals in the United Kingdom.

Chronic intractable pain is continuous pain that has lasted more than six months. Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients. Chronic pain affects one in five adults in Europe, or about 95 million people 15 to 64 years of age.

“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 (also known as 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. Up to now, approximately 350,000 patients with chronic pain have been treated worldwide with SCS therapy.

The Precision Plus SCS system was approved in the United States in 2004 and received approval in Europe and Canada in 2005. The system is the world’s first rechargeable IPG. Today, more than 60,000 patients worldwide have been treated using this system. When compared to nonrechargeable 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.

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