Minneapolis medical device giant Medtronic (NYSE:MDT) launched a new global study of its Specify 5-6-5 spinal cord stimulation 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 PROMISE trial is the 1st large-scale study of its kind to compare assess the value of neurostimulation in treatment of low back pain with leg pain. Prior studies had focused on predominant leg pain, according to a press release.
Medtronic researchers will treat patients at centers in the U.S., Canada and Europe, randomizing them 1-to-1 to either the device or the control arm and looking for a 50% reduction in reported pain at 6 months following initiation.
"Spinal cord stimulation has become an increasingly valued treatment approach in chronic pain, and we look forward to participating in the latest study,
" global principal investigator Dr. Philippe Rigoard said in prepared remarks. "If the PROMISE results are positive, they will provide critically needed relief for those patients suffering from chronic low back pain associated with FBSS.
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.
Boston Scientific nearly sold its neurostimulation division in 2010, but the Natick, Mass.-based medical device maker spiked the deal when bids didn’t rise high enough. The company then doubled down on its pain management division with a $78 million buyout of Intelect Medical, developer of the Guide deep-brain stimulation programming system.
Rival device maker St. Jude has had some troubles with its neurostim implants in recent years, including the recall of some of its Eon and Eon Mini pain management implants after hundreds of the neurostimulation devices had to be taken out when their batteries failed too soon or because they overheated while recharging.