Medtech titan Medtronic (NYSE:MDT) enrolled the initial patients in its SubQStim II pivotal clinical trial, evaluating the use of peripheral nerve stimulation in treatment of chronic back pain.
The new study is the latest in a handful of neurostimulation trials launched by the medical device giant as it continues to battle rivals in the market for neurostimulation systems that treat chronic pain.
Patients enrolled in the SubQStim II trial received implanted electrical leads under the skin of the lower back. The leads connect to an electrical pulse generator that delivers mild pulses of energy to interrupt pain signal on their way to the brain.
The randomized, multi-center clinical study will enroll up to 323 patients at up to 30 centers in the U.S. Patients will be randomized to either a control group or neurostimulation treatment for 3 months and follow-up will continue for up to 5 years, according to a Medtronic press release.
"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," principal investigator Dr. Yeshvant Navalgund said in prepared remarks.
The medical device maker is already in the midst of other spinal cord stimulation studies. Earlier this year Medtronic launched a new PROMISE global study of its Specify 5-6-5 therapy in treatment of patients with failed back surgery syndrome and predominant low back pain.
The PROMISE study, which will enroll up to 300 patients, will evaluate treatment with Specify SCS and drug therapy and compare it to treatment with drug therapy alone. The trial is the 1st large-scale study of its kind to assess the value of neurostimulation in treatment of lower back pain with leg pain. Prior studies had focused on predominant leg pain.
Medtech industry giants have long been battling to lead the market for neurostimulation systems that treat chronic pain. Medtronic as well as rivals Boston Scientific (NYSE:BSX) and St. Jude Medical (NYSE:STJ) have been fortifying their pain management portfolios with neurostimulation implants, with much of the fight taking place in European markets.
In August 2012 Boston Scientific touted expanded CE Mark approval in the European Union for its Precision Plus spinal cord stimulator, the 1st rechargeable implantable pulse generator, which won FDA approval in 2004 and in Europe and Canada in 2005. The device maker won another CE Mark for its Precision spectral SCS system in December 2012, shortly after notching its 1st commercial implant of the device.
No fully implantable PNS system has yet been approved by FDA regulators, Medtronic noted.
