Medtronic announced the first patient enrolments in the SubQStim II pivotal clinical trial to pursue US Food and Drug Administration (FDA) approval of peripheral nerve stimulation, also known as subcutaneous nerve stimulation, for the reduction of chronic, intractable post surgical back pain.
Medtronic received CE mark for the first 16-electrode, fully implantable system for the percutaneous delivery of peripheral nerve stimulation in the management of chronic back pain in May 2011, according to the company.
Peripheral nerve stimulation using a fully implantable system is not currently approved by the FDA for use in the USA. The SubQStim II pivotal study is a randomised, controlled, blinded, parallel arm, multicentre trial to assess the safety and efficacy of peripheral nerve stimulation for chronic, intractable post surgical back pain.
The study is expected to recruit up to 323 people at 30 US centres who will receive peripheral nerve stimulation using a Medtronic neurostimulation system. Patients will be randomised to a treatment or control group for the first three months and will continue to participate in open-label follow-up for up to five years, according to a company release.
“The SubQStim II pivotal study will provide new information about subcutaneous nerve stimulation as a potentially valuable treatment option for US patients with chronic, intractable back pain who have found insufficient relief with other treatment options,” said the study’s coordinating investigator, George Mandybur, associate professor and Director Stereotactic and Functional Neurosurgery at the University of Cincinnati and a neurosurgeon with the Mayfield Clinic, USA.
The first enrolments were performed by principal investigators Yeshvant Navalgund, DNA Advanced Pain Treatment Center in Greensburg, Pennsylvania, USA, and D Joseph Meyer, Columbia Interventional Pain Center in Columbia, USA. “Study findings will provide an unprecedented understanding of how leads placed in the subcutaneous tissue layer work with neurostimulation devices to help patients manage their chronic back pain,” said Navalgund.
Medtronic recently initiated the SubQStim I post-market study in Europe, Israel, Australia and Canada to evaluate the effectiveness of peripheral nerve stimulation plus optimal medical management for low back pain, compared to optimal medical management alone in patients with failed back surgery syndrome.
In January, the company announced the beginning of PROMISE, a prospective, randomised study of multicolumn implantable lead stimulation for predominant low back pain. PROMISE is the first ever, large-scale study comparing the effectiveness of Medtronic neurostimulation therapy with Specify 5-6-5 multicolumn surgical leads plus optimal medical management to optimal medical management alone in patients with failed back surgery syndrome and predominant low back pain, according to Medtronic.