St. Jude Medical (NYSE:STJ) said today that it won Health Canada approval for its Prodigy spinal cord stimulator for treating chronic pain.
The 1st Canadian Prodigy implantation was performed May 13 by Dr. Ivar Mendez of the University of Saskatchewan, St. Jude said.
The Prodigy device is designed to deliver low levels of electricity to nerve fibers in the spinal cord to interrupt or mask pain signals as they travel to the brain, St. Jude said. The device also uses St. Jude’s proprietary "burst stimulation" that the company claims reduces or eliminates paresthesia.
"Burst stimulation is a novel technology for SCS that has the potential to be effective in patients that do not respond well to traditional tonic stimulation. Studies have shown that with Burst stimulation patients can experience reduced paresthesia and pay less attention to their pain improving their overall experience with SCS therapy. SCS therapy can provide significant pain relief and thus enable many patients to increase their activity levels and improve their overall quality of life. In combination with conventional tonic stimulation, Burst stimulation represents a comprehensive approach to effective pain management and allows me to tailor the therapy to my patient’s unique situation," Mendez said in prepared remarks.
St. Jude won CE Mark approval in the European Union for its Prodigy device in March 2014, and launched a 442-patient clinical trial in late 2013 under an investigational device exemption in the U.S., seeking a chronic pain indication from the FDA.
Earlier this month the FDA granted pre-market approval to the Senza chronic pain device made by Nevro Corp. (NYSE:NVRO), which is also designed to eliminate paresthesia.
