superion indirect decompression system reviews

For patient satisfaction and treatment approval, the maximum number of patients providing follow-up data was 751, 1,542 and 443 at 3 weeks, 6 and 12 months, respectively. Note: Image courtesy of Vertiflex, Inc. 2011;8(4):419–426. The authors report no other conflicts of interest in this work. This simple and streamlined procedure can be completed at an outpatient center. Requests for data sharing can be made by contacting the corresponding author. 6 , 7 Briefly, the device may be implanted under general anesthesia, conscious sedation (i.e. The device is designed to achieve indirect spinal decompression for patients suffering from neurogenic intermittent claudication due to moderate lumbar spinal stenosis. GT reports grants from Vertiflex, during the conduct of the study. Superion™ Indirect Decompression System If your leg and back pain are keeping you from enjoying your daily life, it’s time to learn about a clinically proven, long-term solution. •  Associations & Partners   The approximate 4% frequency of revision or reoperation captured in our phone survey within the initial 6–12 months following IPD is somewhat lower than the 6-month revision rate of 7% (13 of 190) reported in the regulated clinical trial of Superion.7 The low rate of revision estimated in this survey may be related to a tendency for more compliant patients with better outcomes to participate in post-market surveillance. Most IPD procedures are now undertaken in the ASC setting which avoids the expenditures and complications associated with a hospital admission, and offers a significant reduction in health-care costs to the insurer and patient. Among those patients in the clinical trial that were followed up through sixty months after surgery, almost all expressed overall satisfaction with the Superion implant. EGEMS (Wash DC). •  Top, © Copyright 2020  •  Dove Press Ltd   However, now there is a minimally invasive medical solution that may help: it is the Superion Indirect Decompression System. These registry findings further support the continued clinical adoption of this beneficial treatment in patients considering minimally invasive options to manage neurogenic claudication symptoms due to LSS. The Vertiflex™ Procedure uses a small spacer that is placed inside the spine without damaging any nearby bone or tissue. It is also for patients whose medical history shows that Superion may be their best treatment option because traditional spinal surgery could be too demanding. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms. Bridging unmet medical device ecosystem needs with strategically coordinated registries networks. From submission to first editorial decision. Clin Interv Aging. JEB is an independent advisor to Vertiflex and was remunerated for assistance in manuscript development. The insertion instrumentation is then removed, leaving the implant in place. The primary aim of the registry is to prospectively collect a set of perioperative and clinical outcomes among patients treated with stand-alone IPD for symptomatic LSS. They support your head and body while the discs act as “shock absorbers.”. The regimen may include, but need not be limited to: medications, a corset or brace, acupuncture, traction, physical therapy, chiropractic treatment, use of a TENS unit and massage therapy. Average intraoperative blood loss was 6.1 ± 7.3 mL and the mean operative duration was 44.1 ± 24.9 mins. This initial report of the PRESS registry and a direct-to-patient phone survey corroborates, expands and compliments previously published studies of this device. Leaning forward causes the spinal canal to open,which relieves pressure on the nerves. All rights reserved. 20160638), and all patients provided written informed consent. open access to scientific and medical research. It is a minimally invasive procedural option while providing the patient with spinal relief. Mean leg pain severity decreased from 76.6 ± 22.4 mm preoperatively to 30.4 ± 34.6 mm at 12 months, reflecting an overall 60% improvement. Three-hundred sixteen physicians at 86 clinical sites in the US participated. The Vertiflex™ Procedure (Superion™ Indirect Decompression System) is redefining the treatment of LSS for patients. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. Additionally, we speculate that improvement in patient selection by controlled and well-selected physician training in the IPD procedure during the post-market period may have contributed to a reduction in the risk of subsequent revision. Many patients have a hard time finding such relief due to the fact that most other treatments are invasive. There’s a simple and safe procedure that may help you get back to enjoying your day-to-day life again. The vertebrae join together like links in a chain. •  Recommend this site Impact of clinical registries on quality of patient care and clinical outcomes: a systematic review. In the phone survey, the rate of revision was 3.6% (51 of 1,426).Conclusion: These registry findings support the clinical adoption of minimally invasive IPD in patients with neurogenic claudication associated with LSS.Keywords: Superion®, interspinous spacer, lumbar spinal stenosis, neurogenic claudication, decompression, Approval of a second-generation, stand-alone intervertebral spacer by the US Food and Drug Administration in 2015 has led to renewed enthusiasm for the use of interspinous process decompression (IPD) as an effective treatment option for symptomatic lumbar spinal stenosis (LSS). A large number of interspinous process devices (IPD) have been recently introduced to the lumbar spine market as an alternative to conventional decompressive surgery in managing symptomatic lumbar spinal pathology, especially in the older population. Interspinous process decompression improves quality of life in patients with lumbar spinal stenosis. In addition, the Vertiflex™ Procedure offers the following benefits: The Spine & Nerve Centers at The Saint Francis Hospital, The Spine & Nerve Centers at Logan Regional Medical Center, The Spine & Nerve Centers Physical Therapy and Functional Restoration Center, The Spine & Nerve Centers at CAMC Teays Valley Clinic, The Spine & Nerve Centers at CAMC Memorial Hospital, Physical Therapy and Functional Restoration Center, Clinically proven to show relief lasting for five years, Non-opioid solution that can help reduce pre-existing opioid use, No removal or disruption to any bone or tissue, Can be performed in an outpatient setting, Completely reversible, leaving all treatment options available in the future. The poster’s abstract was published in Proceeding of the 34th Annual Meeting of the North American Spine Society/The Spine Journal 19(2019)S74: UK VAT Group: GB 365 4626 36. Graphical support was provided by Terry Meredith. Nunley PD, Deer TR, Benyamin RM, Staats PS, Block JE. Characterization and description of the device system, procedural details and surgical technique have been published previously.6,7 Briefly, the device may be implanted under general anesthesia, conscious sedation (i.e. 2018;11:2943–2948. If your leg and back pain are keeping you from enjoying your daily life, it’s time to learn about a clinically proven, long-term solution. Outcomes included intraoperative blood loss, procedural time, leg and back pain severity (100 mm VAS), patient satisfaction and treatment approval at 3 weeks, 6 and 12 months.Results: The mean age of registry patients was 73.0 ± 9.1 years of which 54% were female. Registries are playing an increasingly important role in monitoring the quality of care, providing technical feedback, and for supplying a platform for the ongoing conduct of research.4,10 This medical device registry was initiated to capture real-world, pragmatic experience regarding the clinical utilization and performance of IPD for patients with symptoms of neurogenic claudication secondary to LSS. The Superion implant produces the same effect—relieving pressure on the nerves—but without leaning forward. The mean age of registry patients was 73.0 ± 9.1 years including 54% females. This canal is surrounded by the vertebrae and protects a cylinder of nerves called the spinal cord. The Superion Indirect Decompression System was developed for patients with moderate spinal stenosis who have tried six months of conservative care treatment without finding relief from their pain. 401, San Francisco, CA 94115, USATel +1 415 775 7947Email [email protected]: Interspinous process decompression (IPD) with stand-alone spacers has demonstrated excellent long-term clinical benefit for patients with lumbar spinal stenosis (LSS).Methods: IPD used the Superion® Indirect Decompression System (Vertiflex, Carlsbad, CA, USA). After implantation of the Superion® IDS or performance of the direct decompression, each Investigator will be permitted to provide a postoperative care regimen based on the subject's specific need. All post-operative care instructions should be prescribed by your physician. Mean leg pain severity decreased from 76.6 ± 22.4 mm preoperatively to 33.0 ± 29.9 mm at 3 weeks, 33.1 ± 34.0 mm at 6 months, and 30.4 ± 34.6 mm at 12 months, reflecting an overall 60% improvement (Figure 2).

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