FDA Approves New Component for Boston Scientific Spinal Cord Stimulator

New technology will lead to more consistent lead anchoring with spinal cord stimulators in patients with chronic intractable pain of the trunk or limbs.

Medical device developer and manufacturer Boston Scientific today reported that the US FDA has approved the Clik Anchor for its Precision Plus Spinal Cord Stimulator (SCS) System, which Boston Scientific describes as “the world's first rechargeable SCS device for chronic pain management.” The company plans to debut the Clik Anchor at the American Academy of Pain Medicine Annual Meeting, which begins today.

The Clik Anchor features an “innovative locking system designed to improve lead anchoring speed and consistency” and provide “tactile and audible confirmation for physicians that the lead is secured.” Michael Onuscheck, Senior Vice President and President of Boston Scientific's Neuromodulation Division, said that this latest addition to Boston Scientific’s other SCS percutaneous lead products “gives physicians the most comprehensive array of lead options in the market.”

The Precision Plus SCS System “is indicated as an aid in managing chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.”

Other Spinal Cord Stimulator News from Boston Scientific

Boston Scientific is currently sponsoring the “Spinal Cord Stimulation With Precision® SCS System Versus Reoperation for Failed Back Surgery Syndrome” trial. Also referred to as the “EVIDENCE trial,” this is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed Back Surgery Syndrome (FBSS). The two primary study endpoints are proportion of subjects with ≥50% leg pain relief without crossover at 6 and at 24 months.

Inclusion criteria include chief complaint of radicular leg pain, with or without low back pain after one or more lumbosacral surgical procedures, leg pain intensity of 5 to 10 on standard 0-10 NRS with a duration of at least six months, and MRI or CT myelogram of the lumbar and thoracic spine rules out a pathology that might compromise SCS electrode placement or pathology in addition to neural compression that might contribute to the subject's pain.

Patients whose chief complaint is low back pain; who have radiographic evidence of frank instability requiring fusion, calcific arachnoiditis, or severe thoracic stenosis; or have a potentially disabling neurologic deficit in the distribution of a nerve root or roots caused by surgically remediable compression are disqualified from participation in this trial. Go here for a complete list of inclusion and exclusion criteria.

HCPLive wants to know:

Do you recommend the use of spinal cord stimulation for some of your patients with intractable low back pain and leg pain who have not responded to back surgery?

Have you used this particular brand of spinal cord stimulator? Have your experiences been favorable?

If you do not recommend the use of spinal cord stimulation in your patients, what other remedies or treatments do you favor?

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