Celéri Health Announces Enrollment of First Patient in Study of Real World Outcomes® for Medtronic DTM™ Spinal Cord Stimulation (SCS)
The clinical study is sponsored by Celri Health and is supported by Medtronics External Research Program.
WILMINGTON, Del., Feb. 23, 2021 (GLOBE NEWSWIRE) -- Celéri Health, a leader in using Real World Outcomes® to change the paradigm of care for people living with chronic pain, today 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. The first patient was enrolled on January 29, 2021 at Jax Spine & Pain Centers in Jacksonville, Florida by Dr. Michael Hanes.
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.
DTM SCS therapy is a proprietary spinal cord stimulation algorithm available to treat patients with chronic pain that is delivered as a programming option via the Medtronic Intellis platform. The DTM waveform may engage a novel mechanism that modulates both neurons and glial cells and has been studied in animal models, showing statistically significant reversal of pain behaviors compared to either low frequency or high frequency conventional stimulation alone.1,2
In a recent randomized 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.3
“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 Dr. Jason Pope, co-founder of Celéri Health.
“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 Dr. 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.
About the UPGRADE Study
This study is a prospective, multicenter, single-arm real-world outcomes registry study where Patients will be followed for 24-months to assess the impact of DTM programming on the multidimensional efficacy of the Intellis spinal cord stimulation platform compared to baseline. Please refer to www.clinicaltrial.gov (NCT04725838) for additional clinical trial details.
About Dr. Michael Hanes
Dr. Michael Hanes, MD is a board-certified Anesthesiologist and Interventional Pain Medicine specialist. He is a leading expert in the treatment of chronic pain and neurostimulation in Northeast Florida. Dr. Hanes is a published educator and national speaker in the field of interventional pain management and is a strong proponent of providing safe, effective and empathetic care options to patients experiencing chronic or acute pain.
About Jax Spine & Pain Centers
Jax Spine & Pain Centers (https://jaxspine.com) is North Florida’s leading provider in progressive interventional pain relief with centers located in Jacksonville, St. Augustine, Fleming Island, and Fernandina.
About Dr. Jason Pope
Dr. Jason Pope, MD (Evolve Restorative Center in Santa Rosa, Sonoma, Healdsburg, and Lakeport, California) is regarded as one of the most influential key opinion leaders in the field of pain medicine and neuromodulation. He is triple boarded in Pain Medicine, has published over 100 peer reviewed journals and has spoken at numerous national and international conferences. He is committed to bring innovative treatments to patients around the world and treats every patient with dignity and empathy. As a co-founder of Celéri Health, Dr. Pope is committed to redefining outcomes metrics used to measure response to pain care and neuromodulation through the clinical development of the Real World Outcomes® platform.
About Celéri Health
Celéri Health (www.celerihealth.com) is a real-world evidence company whose mission is to use patient-centric data to develop Real World Outcomes® to accelerate drug and device discovery, and improve care and quality of life for people living with pain.
Forward-Looking Statements
Any forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and are subject to risks and uncertainties. Actual results may differ materially from anticipated results. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward-looking statements. These statements speak only as of the date of this press release and Celéri Health does not assume any obligation to update or revise them to reflect new events or circumstances that exist after the date as of which the forward-looking statements were made.
DTM Spinal Cord Stimulation and Intellis are registered trademarks of Medtronic.
References
1Vallejo R, Kelley CA, Gupta A, Smith WJ, Vallejo A, Cedeño DL. Modulation of neuroglial interactions using differential target multiplexed spinal cord stimulation in an animal model of neuropathic pain. Mol Pain. 2020 Jan-Dec;16:1744806920918057.
2 Cedeño DL, Smith WJ, Kelley CA, Vallejo R. Spinal cord stimulation using differential target multiplexed programming modulates neural cell-specific transcriptomes in an animal model of neuropathic pain. Mol Pain. 2020 Jan-Dec;16:1744806920964360.
3Fishman M, Cordner H, Justiz R, et al. Randomized Controlled Clinical Trial to Study the Effects of Differential Target Multiplexed™ SCS (DTMTM SCS) in Treating Intractable Chronic Low Back Pain: Long-term Follow-Up Results. Presented at: North American Neuromodulation Society 24th Annual Meeting. Jan 15-16, 2021. Virtual.
Contact Information Celéri Health Jon Brilliant, Chief Executive Officer [email protected]
