Two New Uses Approved for Boston Scientific Spine Stimulator

Boston Scientific Corp. has received CE Mark approval for two separate uses of the Precision Plus Spinal Cord Stimulator (SCS) System. The first is its indication for peripheral nerve stimulation for patients with chronic intractable pain of the trunk. Peripheral nerve stimulation provides doctors and patients with an additional treatment option for managing chronic intractable pain of the trunk by stimulating peripheral nerves through a small surgically implantable device. The second is the approval of its use in patients who also need magnetic resonance imaging (MRI) head-only scans.

“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,” said David Abejón, M.D., consultant anesthetist at Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.

Chronic intractable pain is continuous pain has lasted more than six months. Living in constant pain for an extended period time can have a devastating impact to quality of life for many patients. Without relief, or the hope for relief, many patients lose the ability to sleep, work, and function normally.

“Chronic pain affects nearly 95 million adults throughout Europe,” said Michael Onuscheck, senior vice president and president of Europe, Middle East and Africa, at Boston Scientific. “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.”

“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. M.D., FFPMRCA, consultant in pain medicine and neuromodulation at Basildon and Thurrock University Hospitals in the United Kingdom.

The 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 implantable pulse generator. According to Boston Scientific, more than 60,000 patients worldwide have been treated using this system. The company claims that 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.

Boston Scientific is based in Natick, Mass., and produces a range of medical devices for a variety of markets. The Precision Plus system is part of its neuromodulation business.