Boston Scientific's Spinal Cord Stimulator "Gamble" Pays Off
Data from a long-term LUMINA study demonstrated that Boston Scientific’s Precision Spectra Spinal Cord Stimulator (SCS) offered a 70 percent improvement in lower back pain relief compared to the previous generation of the device. Investigators reported that the system provided “sustained and highly significant reduction in overall pain” for a wide range of patients who suffer from chronic pain.
The Precision Spectra SCS was launched in the U.S. in 2013, and prior to its release, SCS systems — including Boston Scientific’s Precision — offered 16 contacts and two lead ports with each port offering a single lead. In comparison, the Precision Spectra boasted 32 contacts and four lead ports—providing a wider range of coverage and more therapeutic flexibility.
The Precision Spectra SCS System also includes the Illumina 3D Software, SCS programming software based on 3D, anatomically correct computer-modeled spinal cords. When a doctor selects an area of the spine for treatment, the software designs a customized stimulation field.
Michael Moffitt, R&D director in Boston Scientific’s Neuromodulation unit, told Popular Mechanics that he and his team didn’t have any clinical data to suggest more contacts would improve therapy, and he called the design of the Precision Spectra “something of a gamble.”
Giancarlo Barolat, medical director at Barolat Neuroscience, called the system a “paradigm shift.”
Two years later, the LUMINA cohort has collected data from four patient groups, which demonstrate “sustained and highly significant reduction in overall pain” compared to the Precision Plus. Patients who were treated with each system consecutively displayed an average 70 percent improvement in pain reduction with the newer system. A subset of patients with severe lower back pain (rated 8 or above) dropped to an average score of 2.98 after 24 months of treatment.
“As the LUMINA data show, the Boston Scientific Illumina 3D Algorithm allows me to treat low back pain more consistently and effectively than before,” said James North, a pain specialist at the Carolinas Pain Institute. “These data are impressive because they demonstrate sustained long term pain relief in an all-comers population; we did not exclude the type of challenging patients that physicians see every day.”
Initial results from the study were announced in June, but the finalized results were presented at the North American Neuromodulation Society (NANS) annual meeting held last weekend in Nevada. In addition, Boston Scientific hosted a symposium that highlighted the Precision Spectra SCS’s MultiWave technology, which allows doctors to personalize SCS treatments for individual patient needs.
According to a recent Institute of Medicine report, chronic pain costs the U.S. economy between $560 billion and $635 billion each year, a figure that includes both the cost of health care and lost productivity. The World Health Organization (WHO) names lower back pain as the world’s leading cause of disability, occurring in similar proportions in all cultures around the globe.