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2017;5(1):26. This work is published and licensed by Dove Medical Press Limited. 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. The procedure involves no tissue or bone damage and minimal blood. •  Testimonials   Start enjoying your day-to-day life again. •  Terms & Conditions   This is called lumbar spinal stenosis (LSS). After the procedure, you may enjoy significant reduction in leg pain within the first few days. •  Recommend this site 2. Responder rates were computed for leg and back pain (≥20 mm improvement), patient satisfaction (satisfied/somewhat satisfied), and treatment approval (yes/probably yes). It can provide a solution for the ongoing leg and back pain with minimal recovery time to help stenosis sufferers return to enjoying day-to-day life again. The minimally invasive nature of IPD implantation allows for the procedure to be performed in an ambulatory surgical center (ASC) under monitored anesthesia care. DS reports personal fees from Vertiflex, outside the submitted work. Once the cannula is in place, a sizing tool is employed to determine the proper device size. A medical device registry was established at several clinical sites in the US to track the ongoing performance and clinical utility of IPD with a stand-alone interspinous spacer in a real-world clinical practice setting.5 Herein, we provide characterization of patients enrolled in the registry with respect to perioperative factors and postoperative clinical outcomes. Interspinous spacer implant in patients with lumbar spinal stenosis: preliminary results of a multicenter, randomized, controlled trial. At each follow-up interval, patient satisfaction with the procedure was queried as satisfied, somewhat satisfied, somewhat dissatisfied, or dissatisfied. Ability to sit for 50 mins without pain and to walk 50 feet or more. 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. 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. This outpatient procedure can be done with light anesthesia or while you remain awake and has minimal recovery time. In order to provide our website visitors and registered users with a service tailored to their individual preferences we use cookies to analyse visitor traffic and personalise content. Copyright 2017 Informa PLC. Certain risks are associated with the use of the Superion. doi:10.2147/CIA.S143503. 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. They support your head and body while the discs act as “shock absorbers.”. Overall patient impression of and treatment approval with IPD was characterized as definitely yes, probably yes, probably not or definitely not with respect to whether the patient would repeat the treatment. The Superion ISS can be implanted under general or local anesthesia. 2017;12(9):e0183667. 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. 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. Several features of Spinal stenosis is the result of aging and “wear and tear” on the spine from everyday activities. The Vertiflex™ Procedure is the only FDA approved, minimally invasive, indirect decompression device to treat lumbar spinal stenosis. Nunley PD, Deer TR, Benyamin RM, Staats PS, Block JE. 401, San Francisco, CA 94115, USATel +1 415 775 7947Email jb@drjonblock.comBackground: 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). Our decompression system provides patients suffering from spinal stenosis with relief. 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. The procedure can be performed in either the hospital operating room or an outpatient surgical center. Corresponding responder rates were 64% (484 of 754), 72% (1,097 of 1,523) and 75% (317 of 423) at 3 weeks, 6 and 12 months, respectively. This preserves the necessary space in the spine, lifting pressure off the nerves in the lower back which can result in the reduction or elimination of leg and back pain. 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. this site will not function whilst javascript is disabled. 25% to 50% reduction in the central canal and/or nerve root canal (subarticular, neuroforaminal) compared to the adjacent levels on radiographic studies, with radiographic confirmation of any one of the following: Evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements. Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH. Patient-reported outcomes comprised leg and back pain severity by 100 mm visual analog scale prior to IPD as well as at 3 weeks, 6 and 12 months, post-operatively. Titanium is biocompatible and reduces the risk of inflammation or rejection. doi:10.2147/JPR.S182322, 4. •  software development by maffey.com Impact of clinical registries on quality of patient care and clinical outcomes: a systematic review. 3. 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. JAMA. Your spine is made up of a flexible column of 24 bones called vertebrae. Krucoff MW, Sedrakyan A, Normand SL. If you have moderate LSS with radiating leg pain and have been treated with non-surgical options for at least 6 months with no relief from your symptoms, the Superion IDS may be a favorable treatment option for you. From editorial acceptance to publication. Register your specific details and specific drugs of interest and we will match the information you provide to articles from our extensive database and email PDF copies to you promptly. There’s a simple and safe procedure that may help you get back to enjoying your day-to-day life again. He also received personal fees from Boston Scientific and Vertiflex, outside the submitted work. Number 3099067. The Vertiflex Superion Interspinous Spacer (ISS) is a motion-preserving, indirect decompression spinal implant system for the treatment of moderate lumbar spinal stenosis. Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH. Graphical support was provided by Terry Meredith. The vertebrae join together like links in a chain. Mean leg and back pain severity was computed and illustrated graphically by follow-up interval. doi:10.1001/jama.2015.11036, 6. Leg and back pain may be the result of a condition called lumbar spinal stenosis (LSS). It is a minimally invasive procedural option while providing the patient with spinal relief. Bridging unmet medical device ecosystem needs with strategically coordinated registries networks. Average intraoperative blood loss was 6.1 ± 7.3 mL and the mean operative duration was 44.1 ± 24.9 mins. Hoque DME, Kumari V, Hoque M, Ruseckaite R, Romero L, Evans SM. J Pain Res. Expert Rev Med Devices. Patient data were captured from in-person interviews and a phone survey. Note: Image courtesy of Vertiflex, Inc. 6 , 7 Briefly, the device may be implanted under general anesthesia, conscious sedation (i.e. Figure 1 Superion® indirect decompression system. Following FDA approval, real-world experience with stand-alone IPD mirrors the clinical improvements in pain, functional outcomes and patient satisfaction achieved in a regulated clinical trial setting.7 The degree of improvement is robust across all condition-specific outcomes, with a large proportion of patients reporting clinically significant gains at 3 weeks post-procedure in this registry. • Web Design by Adhesion. 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. Often times, people with this condition can’t walk or stand up straight for long periods of time and may frequently need to lean forward or sit for relief. The study protocol and consent forms were approved by an independent institutional review board (Western Institutional Review Board, Puyallup, WA USA, No. Back pain severity improved from 76.8 ± 22.2 mm preoperatively to 37.5 ± 29.6 mm at 3 weeks, 41.9 ± 32.5 mm at 6 months, and 39.9 ± 32.3 mm at 12 months (48% improvement) (Figure 2), with 3 weeks, 6- and 12-month responder rate of 61% (457 of 752), 67% (1,033 of 1,539) and 67% (297 of 441), respectively. Superion interspinous process spacer for intermittent neurogenic claudication secondary to moderate lumbar spinal stenosis: two-year results from a randomized controlled FDA-IDE pivotal trial. Many patients have a hard time finding such relief due to the fact that most other treatments are invasive. Findings from a randomized controlled trial likewise demonstrated that symptom relief with IPD is immediate, with improvements that are maintained through 5 years of follow-up.1,9. Back pain severity improved from 76.8 ± 22.2 mm preoperatively to 39.9 ± 32.3 mm at 12 months (48% improvement); 12-month responder rate of 67% (297 of 441). The opinions expressed in all articles published here are those of the specific author(s), and do not necessarily reflect the views of Dove Medical Press Ltd or any of its employees. JEB is an independent advisor to Vertiflex and was remunerated for assistance in manuscript development. For this intended use, moderate degenerative lumbar spinal stenosis is defined as follows: Data collection in this registry was captured from in-person interviews and a phone survey, and included intraoperative blood loss and procedural time. All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work. •  Sitemap   It is made of titanium, a material used for medical implants because it is lightweight with great strength. https://www.thespinejournalonline.com/article/S1529-9430(19)30355-9/pdf, Creative Commons Attribution - Non Commercial (unported, v3.0) License.

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