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ReGelTec has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for the HYDRAFIL System for disc augmentation. The system is an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain and improve daily function without the need for an invasive surgery.
The study follows the company’s receipt of CE Mark for the HYDRAFIL System based on promising results of clinical studies performed outside the United States on 75 patients. The studies showed that patients treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability, with more than 80% improvement in Oswestry Disability Index scores and greater than 70% reduction in Numeric Pain Rating Scale scores, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit.
The HYDRAFIL-D study is a 225-patient, multicenter, single-blinded, randomized, controlled trial evaluating the safety and effectiveness of the HYDRAFIL System to support FDA approval. The study will measure improvements in pain and disability, reliance on opioid medications, and the need for invasive medical procedures in patients with chronic low back pain due to degenerative disc disease. The protocol includes an interim safety analysis when the first sixty patients complete their six-month follow-up visit.
Performed in an outpatient procedure under local anesthesia, ReGelTec’s HYDRAFIL System delivers a permanent hydrogel into a degenerated disc via a needle to fill cracks and fissures and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain.
Source:Â ReGelTec
ReGelTec has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for the HYDRAFIL System for disc augmentation. The system is an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain and improve daily function without the need for an...
ReGelTec has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for the HYDRAFIL System for disc augmentation. The system is an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain and improve daily function without the need for an invasive surgery.
The study follows the company’s receipt of CE Mark for the HYDRAFIL System based on promising results of clinical studies performed outside the United States on 75 patients. The studies showed that patients treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability, with more than 80% improvement in Oswestry Disability Index scores and greater than 70% reduction in Numeric Pain Rating Scale scores, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit.
The HYDRAFIL-D study is a 225-patient, multicenter, single-blinded, randomized, controlled trial evaluating the safety and effectiveness of the HYDRAFIL System to support FDA approval. The study will measure improvements in pain and disability, reliance on opioid medications, and the need for invasive medical procedures in patients with chronic low back pain due to degenerative disc disease. The protocol includes an interim safety analysis when the first sixty patients complete their six-month follow-up visit.
Performed in an outpatient procedure under local anesthesia, ReGelTec’s HYDRAFIL System delivers a permanent hydrogel into a degenerated disc via a needle to fill cracks and fissures and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain.
Source:Â ReGelTec
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
