Celéri Health has announced the first patient has been enrolled in the UPGRADE study which is a large registry of patients using DTM Spinal Cord Stimulation (SCS) available only on the Medtronic Intellis platform. According to a company press release, the first patient was enrolled on 29 January, 2021 at Jax Spine & Pain Centers in Jacksonville, USA by Michael Hanes.
According to Celéro Health, the UPGRADE registry will capture long-term, real-world outcomes to understand the effect of DTM SCS programming in the SCS implanted population on the management of chronic pain, primarily on its use for trunk and/or limb pain. The clinical study is sponsored by Celéri Health and is supported by Medtronic’s External Research Program. The registry study will be conducted across approximately 20-30 centers in the United States with up to 1700 patients enrolled.
“DTM therapy is the first tailored SCS approach intentionally developed from a novel scientific concept and demonstrated in a RCT. Physicians are seeing great patient outcomes since we launched the therapy earlier last year. We’re excited to see another study expand on the strong body of evidence that exists today,” said Charlie Covert, vice president and general manager of the Pain business, which is part of the Neuromodulation Operating Unit at Medtronic.
Celéri Health reports that in a recent randomised controlled trial (RCT) evaluating DTM SCS versus conventional SCS, DTM SCS showed statistically significant (p=0.0009) and superior back pain relief compared to conventional SCS. Both arms used the Medtronic Intellis platform. Twelve-month results showed 84% of patients with chronic back pain treated with DTM SCS reported at least 50% pain relief, compared with 51% of patients treated with conventional SCS and 69% of subjects in the DTM SCS group achieved a profound response for back pain, which was defined as greater than or equal to 80% pain relief.
“As the leader in capturing and leveraging real-world outcomes in pain care, Celéri Health is pleased to have support from Medtronic for this landmark study. By measuring the impact of DTM SCS therapy on patients’ quality of life using the PROMIS-29, we can really start to understand what ‘better’ means in pain care and neuromodulation,” said on January 29, 2021 at Jax Spine & Pain Centers in Jacksonville, Florida by Dr. Michael Hanes., co-founder of Celéri Health, Wilmington, USA.
“I am pleased to have enrolled the first patient in this important clinical study to help further the clinical understanding of the real-world effectiveness of DTM SCS. I have also successfully used Celéri’s Real World Outcomes platform in my private practice to assess patients using validated Patient Reported Outcomes (PRO) measures to better inform care for my chronic pain patient population,” said Michael Hanes, a participating principal investigator in the UPGRADE study as well as a user of the Celéri Real World Outcomes platform for his practice patients.