Aurora Spine announced publication of the first 6-month clinical evaluation of its ZIP fusion implant. The purpose of this study is to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer-term success.
The REFINE Screwless ZIP Study utilized patient evaluations at three and six months following treatment and is part of an actively enrolling, institutional review board-approved, single-arm, multicenter, prospective, open-label 12-month study. Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index, Visual Analog Scale of the back and leg pain during walking and standing, and Zurich Claudication Questionnaire, and secondarily using the Patient Global Impression of Change and Patient-Reported Outcomes Measurement Information System.
This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device. Analysis showed a sustained improvement in clinical efficacy and safety endpoints when compared to the 3-month evaluations across both interventional pain and neurosurgery specialties.
The ZIP device is an alternative to more invasive traditional spinal surgery. The ZIP System was 510(k) cleared by FDA in 2013 and has been commercially available in multiple sizes in the US since 2014. The ZIP device provides physicians the ability to remove targeted ligament, bone and facet capsule material. This quick decompression involves minimal collateral tissue disruption and can also work under local anesthesia.
Aurora Spine announced publication of the first 6-month clinical evaluation of its ZIP fusion implant. The purpose of this study is to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer-term success.
The REFINE Screwless ZIP...
Aurora Spine announced publication of the first 6-month clinical evaluation of its ZIP fusion implant. The purpose of this study is to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer-term success.
The REFINE Screwless ZIP Study utilized patient evaluations at three and six months following treatment and is part of an actively enrolling, institutional review board-approved, single-arm, multicenter, prospective, open-label 12-month study. Clinical efficacy was assessed primarily using the change from baseline in Oswestry Disability Index, Visual Analog Scale of the back and leg pain during walking and standing, and Zurich Claudication Questionnaire, and secondarily using the Patient Global Impression of Change and Patient-Reported Outcomes Measurement Information System.
This 6-month interim analysis at 42% enrollment of patients was conducted to determine prolonged safety and efficacy of the ZIP interspinous fusion device. Analysis showed a sustained improvement in clinical efficacy and safety endpoints when compared to the 3-month evaluations across both interventional pain and neurosurgery specialties.
The ZIP device is an alternative to more invasive traditional spinal surgery. The ZIP System was 510(k) cleared by FDA in 2013 and has been commercially available in multiple sizes in the US since 2014. The ZIP device provides physicians the ability to remove targeted ligament, bone and facet capsule material. This quick decompression involves minimal collateral tissue disruption and can also work under local anesthesia.
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