|The Precision Spectra Spinal Cord Stimulator--Courtesy of Boston Scientific|
Boston Scientific ($BSX) has released one-year, retrospective data to demonstrate efficacy for its Precision Spectra Spinal Cord Stimulator in treating chronic lower back pain. The company launched the Spectra implant in the U.S. in April 2013, but a change in Medicare reimbursement for these types of devices went into effect on Jan. 1, 2014 putting a damper on reimbursement for spinal cord stimulation systems.
Last quarter, Boston Scientific neuromodulation sales were flat at $115 million for the third quarter of 2014 compared to the same quarter one year earlier. Company execs pointed to the reduction in Medicare reimbursement as the culprit and they weren't optimistic for results in the segment during the fourth quarter either.
"Changes to Medicare reimbursement for physician office trialing of spinal cord stimulation systems went into effect on January 1 and is negatively impacting market growth in 2014," Boston Scientific CFO and EVP Dan Brennan said during the third quarter conference call in October.
"We are facing particularly difficult comparisons in the second half of 2014, given the anniversary of our Precision Spectra launch, coupled with the acceleration of physician office trial into Q4 of last year in anticipation of the reimbursement change," he concluded.
Data published by competitor St. Jude Medical ($STJ) found that under the new regulations, Medicare reimbursement for in-office physician trials of spinal cord stimulation products reduced payment rates by 75% to $1,923 from $7,588.
The latest Spectra data found that in a 12-month analysis of 213 patients at 13 pain centers that it significantly reduced lower back pain. Specifically, patients went from an average baseline of 7.17 on a 0-10 self-reported pain scale to a 2.96 on average.
In 41 patients with severe lower back pain the results were even more impressive with a reduction from 8.60 to 3.17 on the pain scale after 12 months of implantation. The trial will continue through 24-month data.
"Treating low back pain has been challenging because so many therapies have had mixed results," Dr. Salim Hayek, chief of the division of Pain Medicine at University Hospitals of Cleveland and lead study investigator, said in a statement "These results demonstrate that the Precision Spectra System can provide effective, long-term relief for patients suffering from this difficult to treat condition."
- here is the release