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Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

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Mainstay Medical

Mainstay Medical Reports Data from RESTORE Trial of ReActiv8 Implantable Device to Treat Chronic Low Back Pain

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  • The RESTORE trial assessed the ReActiv8 Restorative Neurostimulation therapy (n=99) vs SoC (n=104) for 1yr. to treat intractable chronic low back pain in patients (N=203)
  • The data showed a mean improvement in ODI score (1EP; -19.7 ± 1.4 vs -2.9 ± 1.4), back pain measured by 11-pts. NRS (2EPs; -3.6 ± 0.2 vs -0.6 ±0.2), quality of life measured by EQ-5D-5L test (2EPs; +0.155 ± 0.012 vs +0.008 ± 0.012)
  • In Addition, 72% vs 11% patients had ≥15pts. ODI &/or ≥50% NRS improvement & no worsening in either for 1yr., plus pain remission (≤3 NRS) was observed in 52% vs 6% patients with favorable safety. Data published in Pain & Therapy

Ref: Businesswire | Image: Mainstay Medical

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Disha Nankani

Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.

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