The VertiFlex Superion spacer is inserted through the tube and locked into place against the spine, holding open the spinal column in the area where stenosis was occurring.By creating and maintaining space at the right location, the VertiFlex Superion can provide permanent relief from spinal stenosis pain. How Vertiflex’s Superion can Alleviate Lumbar Spinal Stenosis Symptoms A new minimally invasive treatment option for lumbar spinal stenosis is Vertiflex’s Superion Indirect Decompression System. Preoperatively, the laminectomy group showed slightly higher levels of pain, functional impairment, and condition-specific dysfunction, the authors noted. At 2-years postoperatively, both treatment groups showed “clinically significant gains” across all outcome measures (Table), the authors reported. Ask Dr. McRoberts if Superion is right for you. Does your Dr do the Superion implant for painArizona Pain will soon be taking part in this study, called the PRESS registry. To date, VertiFlex has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis.You may read this website, and believe that you have learned something, but that does NOT replace having the education that comes from having a discussion with a doctor, ANY doctor. The Vertiflex Procedure underwent one of the most rigorous studies on Lumbar Spinal Stenosis.
This website is aimed at familiarizing you with my philosophy. It does not replace a consultation.The Superion ISS system is designed to deliver the implant through a single small incision in the patient’s back, utilizing VertiFlex’ proprietary interspinous access platform. The procedure can be performed under local anesthesia on an outpatient basis and closed with a single suture. Superion’s effectiveness is validated by years of clinical research and is FDA approved. This means most of the tissues of the back are not damaged or disrupted and patients can be discharged the same day and have a faster recovery.How heavy does a person have to be before it is not recommended for them? In addition, these patients reported improved physical function and reduced severity of all symptoms. The Superion device is FDA approved and acts as an extension blocker, allowing the spinal canal to remain extended when standing. Compared to traditional surgeries, this procedure is minimally invasive. This pressure can lead to radiating leg, buttock, and/or groin pain. The VertiFlex Superion provided substantial pain relief, which continued through the entire three-year follow-up period. As we age, the soft tissue or “discs” between the vertebrae (bones that make up the spine) become worn down. This causes the spinal canal to narrow which can put pressure on the nerves in the lower back. Superion is the most advanced, least invasive and currently the only ISS available or in development.Lumbar Spinal Stenosis (LSS) is a degenerative condition of the lumbar spine. Read on to learn more. This procedure involves making an incision in the back and inserting a metal tube that passes between the bones of the spine. Anything you read here is subject to change, may need further explanation, may incompletely describe or fully disclose the risks or benefits of a treatment.
The Superion® ISS is composed entirely of titanium alloy (Ti6Al-4V ELI conforming to ASTM F136 ) The Superion® ISS is intended to be implanted via minimally-invasive surgical methods using a set of proprietary accessory instruments provided by VertiFlex® expressly for use with the Superion® ISS device. 470 patients were enrolled in an Investigational Device Exemption or IDE trial at 29 sites with a 24-month follow-up and annually thereafter through 60 months. VertiFlex is continuing to collect data on the safety and efficacy of the Superion through a non-randomized (meaning all qualifying patients receive the Superion) registry study.VertiFlex developed a procedure for treating spinal stenosis pain with an implanted device called the Superion, an “H” shaped spinal spacer. Superion has been implanted in over 2000 patients worldwide. Click here to see the effects of Superion: https://youtu.be/d0MNGPeulicKey Features of the Vertiflex Superion System Include:Click here to see the full overview of Vertiflex Superion Interspinous Spacer: https://youtu.be/oBW6S3Zsn2gSuperion has been CE marked since 2007 and following a clinical study of 470 patients, was PMA approved by the FDA on May 20, 2015, clearing the way for U.S. commercialization.
Superion is an alternative to traditional surgery, offering a minimally invasive procedure that is simple, safe and effective. Last year, VertiFlex presented this data to the FDA and received approval for this device.
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