|Protégé SCS System for Chronic Pain--Courtesy of St. Jude Medical|
St. Jude Medical ($STJ) is touting two studies of its neurostimulators at the North American Neuromodulation Society meeting in Las Vegas, as it seeks to bring two new forms of stimulation to the U.S., which it believes are better than traditional tonic spinal cord stimulation. Both forms of stimulation are already offered in Europe.
Neuromodulation is a key growth driver at St. Jude Medical, generating $365 million in revenues through Q3 2015, representing a constant currency increase of 17%. One reason is that oral opioid use has come under increasing scrutiny, especially in the U.S., which is projected to accounts for 75% of the $1.6 billion market in 2016, according to company presentation slides.
During the Las Vegas meeting, the company presented results of a 100-patient, randomized study that found patients preferred its Burst stimulation. It hopes to offer Burst stimulation in the U.S. on its Prodigy and Protégé rechargeable spinal cord devices, as well the Proclaim non-rechargeable system.
Over the course of 6 months, patients received both forms of stimulation. One group received St. Jude's Burst stimulation first, and the other received it after traditional spinal cord stimulation.
St. Jude said the trial went beyond its primary endpoint of noninferiority and demonstrated superiority over traditional spinal cord stimulation; 91% of patients reported a decrease in paresthesia (a prickling or burning sensation associated with traumatic nerve damage) following Burst Stimulation, while 65% said they were free of the condition. In addition, among the first 85 patients to complete the study, nearly 70% said they preferred Burst stimulation, according to a release.
Also presented was a study demonstrating that dorsal root ganglion stimulation delivered via the company's CE-marked Axium neurostimulator provides superior relief pain relief than the traditional kind. According to a release, DRG stimulation achieved a success rate of 74% among patients with complex regional pain syndrome or peripheral causalgia, compared to 53% for traditional spinal cord stimulation.
St. Jude hopes the data will help the device attain FDA's stringent PMA approval for high-risk, innovative devices. The company is awaiting word on approval (or rejection) from the agency, following submission of the application in Q1 2015.
According to presentation slides, St. Jude views DRG stimulation as well positioned to treat postsurgical pain following lower extremity amputations, total hip replacement, hernia surgery and total knee replacement.
In other neurostimulation news, StimRelieve just got the FDA's go-ahead to pursue a clinical trial of its percutaneous, implantable wirelessly powered neurostimulator to treat chronic migraine that's resistant to drug therapy.
The Investigational Device Exemption (IDE) enables the company to test the safety and efficacy of occipital and supraorbital nerve stimulation via the StimRelieve Halo Migraine System. StimRelieve aims to demonstrate that the device can reduce the quantity of headaches by 30% at three months without increasing the dosage of medications. The control group will not receive the device during the trial.
The company says the Halo is 95% smaller than other implants, and is implanted using a standard gauge needle rather than invasive surgery to the face, head or neck. In addition, the device does not contain an implanted battery pack. Rather it is powered by an external transmitter worn on the ear, which provides the stimulation.
- read the release about Burst stimulation from St. Jude Medical | here's more about DRG stimulation
- here are the presentation slides from the Las Vegas meeting
- here's the release from StimRelieve