Boston Scientific Corporation has received extended CE Mark approval for use of its Precision™ Plus Spinal Cord Stimulator (SCS) System, to now include peripheral nerve stimulation for patients with chronic intractable pain of the trunk. The company has also confirmed that its CE mark approval now encompasses use of MRI (head-only) scans in patients with the device, providing physicians with an additional diagnostic option for patients with chronic intractable pain.
Chronic intractable pain is classified as continuous pain has lasted more than six months and reportedly affects more than one in five adults, representing some 95 million people in Europe alone. Living in constant pain for an extended period time can have a devastating impact to quality of life for many patients and without relief, or the hope for relief, many patients lose the ability to sleep, work, and function normally.
The Precision Plus SCS System was first approved in the United States in 2004 and received approval in Europe and Canada in 2005 and is the world’s first rechargeable implantable pulse generator. Boston Scientific will no doubt be delighted that its new approval extends the reach of its technology to include peripheral nerve stimulation as this will provide physicians and patients with an additional treatment option for managing chronic intractable pain of the trunk by stimulating peripheral nerves through a what is a small surgically implantable device.
“I am pleased to learn the PRECISION PLUS SCS System has received CE Mark approval for peripheral nerve stimulation,” said Dr. David Abejón, consultant anaesthetist at Hospital Universitario Puerta de Hierro Majadahonda, Madrid. “Based on my clinical experience and research with peripheral nerve stimulation therapy to date, this technique seems to be a promising treatment option in the field of chronic intractable pain management.”
About the MRI compatibility Dr. Simon Thomson, consultant in pain medicine and neuromodulation at Basildon and Thurrock University Hospitals in the United Kingdom said; “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.”
Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa at Boston Scientific said; “Expanding our neuromodulation portfolio to include peripheral nerve stimulation with the Precision Plus SCS System continues our commitment to providing physicians and patients with multiple treatment options for the management of this debilitating condition.”
Source: Boston Scientific Corporation