In a sub-group of 98 subjects, they determined opioid medication prevalence among subjects with a prior history of opioid use. 55-64 VertiFlex, Inc. The use of the Vertiflex® interspinous spacer is a recent minimal invasive procedure useful in the treatment of lumbar spinal stenosis (LSS). US federal law restricts this device to sale by or on the order of a physician. The use of the Vertiflex® interspinous spacer is a recent minimal invasive procedure useful in the treatment of lumbar spinal stenosis (LSS). Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the After the procedure and a healing period of a few weeks, she woke up one day and her lower back pain was gone. Learn about the Vertiflex Superion procedure, a minimally invasive treatment option for patients with mild to moderate spinal stenosis. This level-one evidence-based procedure is supported by data from patients who reported successful outcomes up to five years. (732) 897-4800, 294 Applegarth Road Are you currently being treated by a pain management specialist? Learn about the Vertiflex Superion procedure, a minimally invasive treatment option for patients with mild to moderate spinal stenosis. Monroe, NJ 08831 However, the majority of patients with LSS are elderly and have multiple comorbidities that can make open spinal surgery, even when limited to one level, an anesthesia risk as well as vulnerable to the risk associated with hospitalization and recovery after spine surgery. Available 5 am to 5 pm PT, Monday through Friday, Deliver effective, personalized relief solutions for your patients with back, neck, shoulder, Generally, this procedure is both safe and effective. Despite the fact that they are composed of a wide range of different materials including titanium, polyetheretherketone, and elastomeric compounds, the aim of these devices is to unload spine, restoring foraminal height, and stabilize the spine by distracting the spi… Risks associated with any surgical procedure include: anesthetic medication reactions; blood loss, blood Other causes may include, The symptoms of lumbar spinal stenosis often include. Explore the different kinds of pain so that you can most effectively communicate with your doctors. Any surgery carries the risk of blood loss or a reaction to the anesthetic, as well as pain and discomfort after the procedure. Spinal spacers, also known as Vertiflex, are a treatment for patients with lumbar spinal stenosis with lower extremity numbness, tingling or pain that is relieved with lumbar flexion. Vertiflex Superion in Austin gives you long-lasting relief with minimal risks. 35-44 Neurogenic claudication is a symptom of lumbar spinal stenosis. Get the latest news on innovative pain management solutions from Boston Scientific delivered right to your inbox. When it comes to treating lumbar spinal stenosis, Vertiflex is one of the safest approaches available. Additionally, bruising or inflammation around the incision, infection, and drainage is possible. (609) 488-3988, 1640 Route 88 West Barnegat, NJ 08005 The imaging tests needed to confirm stenosis are MRI and X-ray. Additionally, bruising or inflammation around the incision, infection, and drainage is possible. I'd rather not say, My gender is Such training, which consists of both didactic and laboratory work, is offered by Vertiflex® to those interested in using the device. Superion is safe and effective, and is an excellent choice for patients who haven’t yet found relief, but want to avoid surgery. The Superion Indirect Decompression System is an FDA-approved treatment for moderate LSS. Coding and Payment Guide for Medicare Reimbursement: The following are the 2020 Medicare coding and national payment rates for Interspinous Spacer procedures performed in the outpatient hospital setting. This finding extends previous results with IPD showing long-term sustained clinical improvements, a reduction in symptoms of neurogenic claudication and a decreasing requirement for revision surgery in this population. CALL 732-660-6200 | REQUEST AN APPOINTMENT. Dive into real-world stories and clinical proof of the effectiveness of our personalized pain solutions. Vertiflex is designed for kids up to 12 years old with a maximum weight of 32kg it can be the perfect chair for your baby. Discover more about the different kinds of treatment and the doctors who will try to help you manage your pain. On a scale from 1 to 10, with 1 representing minimal and 10 being most severe, rate your personal pain. Ocean, NJ 07712 Any surgery carries the risk of blood loss or a reaction to the anesthetic, as well as pain and discomfort after the procedure. VertiFlex developed a procedure for treating spinal stenosis pain with an implanted device called the Superion, an “H” shaped spinal spacer. With the use of real-time imaging (fluoroscopic guidance), the surgeon makes one small incision in your lower back and implants the IPD spacer between two spinous processes (e.g., L4-L5). Even though this is a simply performed, minimally invasive procedure, there are some risks involved with the Superion device. Comprehensive Ambulatory Payment Classification (C-APCs) are effective for services performed in … Includes adjustment from 0 to 90 degrees with no risk to the child. (732) 458-2743, 222 Schanck Road Your information has been sent to one of our Patient Care Specialists. After the procedure, you can expect some soreness, and your incision site will have a few stitches or staples that should be kept clean and dry until the first follow-up visit, usually 7 to 14 days after having the procedure. The Superion®, a registered trademark of Vertiflex, Inc., is a device that provides long-term, durable relief of symptoms of intermittent neurogenic claudication for patients with moderate lumbar spinal stenosis. Boston Scientific offers solutions to help manage pain experienced in the back, neck, shoulders, legs, or lower limbs. (732) 660-6200, © 2020 All rights reservedTerms and Conditions | HIPAA Policy | Non-Discrimination Notice, Vertiflex Procedure–Cutting Edge Care for Lumbar Spinal Stenosis, Inherited conditions, such as a small spinal canal or a curved spine, Paget’s disease (a disease that affects the bones), Calcium deposits on ligaments that run along the spine, Pain relief when sitting or bending forward, Numbness or “tingling” feeling in your legs, calves, or buttocks, Aching, dull back pain spreading to your legs, Decreased endurance during physical activities, Pain, weakness, tingling and/or cramping in the legs, buttocks, and/or back (neurogenic intermittent claudication), Using a cane, walker, or shopping cart to move around more comfortably, Cauda equina syndrome (when the nerve roots in your low back are severely compressed, which can permanently affect your movement and sensation), Significant scoliosis (Cobb angle > 10 degrees), Acute fracture of spinous process or laminae fracture, Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1-4), Prior fusion or decompression at the index level. Learn about the different pain relief solutions we offer and which one may be right for you. Donna was excited and hopeful when she learned about Vertiflex Superion. > About Us> Our Office Locations & Hours> Meet Our Physicians> News> Patient Forms> Patient Portal> Pay Your Bill Online> Contact, 500 Barnegat Blvd. If you are experiencing any of these symptoms and/or your doctor has diagnosed you with lumbar spinal stenosis, you may be a candidate for the Vertiflex Procedure. In the meantime, our Patient Education Specialists can help you take the next step toward finding your relief. Light activity, such as walking, is allowed, as tolerated. Vertiflex™ Procedure † You should consult your pain management specialist to make a final determination. In fact, Vertiflex Superion can eliminate the need for major spine surgery for many patients. Superion Vertiflex is an innovative and minimally invasive procedure for the treatment of Lumbar Spinal Stenosis (LSS). Based on your pain score, more information is required, and you may not be qualified for one of our pain management solutions at this time. Vertiflex Superion may eliminate the need for surgery. It is used mostly by interventional pain physicians who can also perform the minimally invasive lumbar decompression (MILD procedure). For the Vertiflex Procedure, a patient is positioned face down on his/her stomach, and a local anesthetic and/or general anesthesia is administered. leg, or lower limb pain. We use a small tube, about as wide around as a dime, to place the spacer under your skin. The degenerative condition is commonly caused by the natural aging process when the discs between the vertebrae become worn down, leading to a narrowing of the spinal canal. Minimally invasive and designed to support the patient’s existing bone structure, the procedure doesn’t involve the removal of any bone or tissue, which reduces the risk of complications for patients while promoting a faster recovery. Vertiflex Superion is a relatively new procedure for treating lumbar spinal stenosis, a common cause of lower back pain in people over 50. Vertiflex Superion provides lasting pain relief without the risks or long recovery time of major surgery. This drug-free therapy can be personalized to deliver lasting relief. Indications for Use. The risks associated with the Vertiflex Procedure include. Developed with patient safety and comfort in mind, this FDA-approved, outpatient treatment aims to give those with lumbar spinal stenosis the freedom to get on with their daily lives, as it offers a significant reduction in symptoms and improves physical function. In the meantime, our Patient Education Specialists can help you take the next step toward finding your relief. Coding and Payment Guide for Medicare Reimbursement: The following are the 2020 Medicare coding and national payment rates for Interspinous Spacer procedures … Contraindications, Warnings, Precautions, Side Effects. During this procedure your doctor will implant the superion device (a small expandable spacer) through a small incision in the lower back into the affected area of the spinal canal. If you are interested in the Vertiflex Procedure for moderate lumbar spinal stenosis, please give Seaview Orthopaedics a call at (732) 660-6200 to schedule a consultation. It is used mostly by interventional pain physicians who can also perform the minimally invasive lumbar decompression (MILD procedure). To make any changes, simply click on the link to your answer below. Vertiflex Procedure Indications, Safety & Warnings, Order Vertiflex Procedure Information Kit. Vertiflex Superion provides lasting pain relief without the risks or long recovery time of major surgery. Boston Scientific Vertiflex™ Procedure† Prescriptive Information The Vertiflex Procedure is redefining the treatment of LSS for patients. The benefits of the Vertiflex procedure include: Minimally invasive procedure Minimal blood loss Reduced risk of infection because there is no open spine surgery Tissue is moved rather than cut so the healing process is simpler Spine is not destabilized There is a high success rate No hospital … This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. Holmdel, NJ 07733 Vertiflex®, Incorporated Page 5 of 55 Potential Adverse Events: The following potential adverse events may occur as a result of interspinous process decompression with the Superion® IDS: 1. Under 35 Together, the implants and manual instruments form a … I'd rather not say. used to implant the Superion® IDS, the implantation procedure, clinical applications for the device, its biomechanics, and adverse events and risks associated with the use of the Superion® IDS. Vertiflex Superion is a safe and simple treatment option for lumbar spinal stenosis. It refers to leg symptoms encompassing the buttocks, groin, and anterior thigh, as well as radiation down the posterior part of the leg to the feet. The National Health Care Guidelines identify the types of back surgery and when they should be performed. The two biggest risks we’re always concerned about are 1) infection—that’s why this is done in the operating room under sterile technique; and 2) bleeding. This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. This procedure provides a number of different benefits, especially when compared to more invasive surgical options. PILD for LSS is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. The Vertiflex Procedure with C. Lan Fotopoulos, M.D. The procedure involves lying face down on an X-ray table. Based on a study published in the Journal of Pain Research in November 2018, the researchers examined and characterized the opioid medication usage patterns among patients treated with stand-alone IPD through 5 years of postoperative follow-up. It provides patients with a clinically proven, minimally invasive solution that is designed to deliver long-term relief from the leg and back pain associated with LSS. The Vertiflex procedure for spinal stenosis is a minimally invasive medical procedure in which a specially designed implant is inserted in the spine to restore the correct spacing. Previously when a patient had clinical symptomatic neurogenic claudication (NC) and radiologic findings … Based on this, more information is required, and you may not be qualified for one of our pain management solutions at this time. The lumbar spine is made up of five bones called vertebrae. Are there any risks associated with the Vertiflex Procedure? Resources. used to implant the Superion® IDS, the implantation procedure, clinical applications for the device, its biomechanics, and adverse events and risks associated with the use of the Superion® IDS. A patient of the Florida Spine Specialists talks about how she feels after having a superion interspinous spacer indirect lumbar decompression surgery. They receive years of advanced training in pain management and focus on treating patients with severe pain. Lumbar spinal stenosis is a gradual narrowing of the space in the spine where nerves pass through. The results indicated that between baseline and 5 years, there was an 85% decrease in the proportion of subjects using opioids, and a decreased opioid medication usage was also observed among the sub-group of subjects with a history of opiates prior to entering the trial. The Vertiflex® interspinous spacer is an FDA-approved indirect decompression device that is implanted between the vertebrae to specifically address the symptoms of lumbar spinal stenosis. You would not be a candidate for the Vertiflex Procedure if you have or have had. The Superion implant is placed in your back through a tiny incision. The most common cause of lumbar spinal stenosis is aging where normal wear and tear on the spine as we age causes changes in the spine. The Vertiflex Procedure uses a small implant (the Superion® Indirect Decompression System) that is placed inside the spine to help prevent reduction of the space when standing or walking. It can relieve leg and back pain. Fortunately, there’s now a new procedure that bridges the gap between surgery and conservative treatment. The use of the Vertiflex® interspinous spacer is a recent minimal invasive procedure useful in the treatment of lumbar spinal stenosis (LSS). For 6 weeks following your procedure, limit all lifting, bending, twisting, and strenuous activity including lifting anything over 10 pounds, swimming, golf, tennis, racquetball, running, jogging, or sexual activity. Which of the following treatments are you currently using or have used in the past? Superion Procedure: A Step Below Surgery Lumbar spinal stenosis is a painful condition in which the spinal canal narrows, compressing the nerves that run down your back and into the legs. Learn more from patients who use these technologies and see how well they work. This procedure is generally described as a non-invasive procedure using specially designed instruments to percutaneously … The procedure takes between 30 to 45 minutes with very little recovery time. These patients must also have failed conservative treatment and are unable or unwilling to undergo open spine surgery. All forms of surgery have the inherent risks of potential infection, nerve injury, allergic reaction, or complications of failure, or re-herniation ( a 10% chance in all types of surgery). The company, founded in 2005 and headquartered in San Clemente, California, has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. You should consult your pain management specialist to determine what treatments are right for you. Boston Scientific Vertiflex™ Procedure † Prescriptive Information Superion™ Indirect Decompression System. 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. At Seaview Orthopaedics, we offer cutting edge care the Vertiflex Procedure for the treatment of moderate lumbar spinal stenosis. Minimally Invasive, Outpatient Implant Procedure. Freehold, NJ 07728 Find useful resources to help you cope with your pain and learn what options there are to help you find relief. With the Vertiflex procedure, you can reduce your risk of spinal degeneration without having to undergo surgery on your spine itself. This provides relief by lifting pressure off the nerves to alleviate leg and back pain symptoms that often accompany the condition. Benefits of the Vertiflex® Interspinous Spacer. Male This procedure involves making an incision in the back and inserting a metal tube that passes between the bones of the spine. Yes, the Vertiflex Procedure is a simple and safe, minimally invasive treatment clinically proven for effective, long-term relief from the pain associated with lumbar spinal stenosis. Pain management specialists are doctors who specialize in all kinds of pain. We can complete the procedure on an outpatient basis, so you won’t have to deal with extensive pain or hassle. Anyone of any age can be affected, but your chances of developing LSS increase with age, and the condition is most common among adults age 60 and up. Complete the information below and a team member will contact you. My age is What Is Vertiflex Superion? These procedures were performed by neurosurgeons and orthopedic spine surgeons. Brick, NJ 08724 The Superion Indirect Decompression System (IDS) is contraindicated for patients who: have spinal anatomy that prevent implantation of the device or cause the device to be unstable in situ (i.e., degenerative spondylolisthesis greater than grade 1), Cauda equina syndrome, or prior decompression or fusion at the index level. health of patients around the world. If you have moderate degenerative LSS and conservative measures are not providing relief, there may not be a need to jump automatically to a surgical solution. IPD involves implanting a device (or spacer), such as the Superion®, between the spinous processes, which are the thin, bony projections on the back of the spine. 1 You have been suffering from pain for . 65 and over 5 You have tried the following treatments: 6 You are by a pain management specialist. An active systemic infection or infection localized to the site of implantation, The implant can become dislodged or moved out of place, Bone may settle around the implant, which is a common risk in people with osteoporosis, The spinous process can fracture when the IPD spacer is implanted, After implantation, the spacer may not provide adequate relief from pain and symptoms, You may need additional surgery to relieve pain and other symptoms. You should consult your pain management specialist to make a final determination. Browse our extensive collection and support resources to find the answers you need. The Superion® device is made of titanium alloy. The other added benefits are that it helps to preserve some spinal motion (unlike spinal fusion that permanently limits movement), there is less blood loss, and there is reduced risk for infection. The primary analysis included all 190 patients randomized to receive the Superion® device. (732) 462-1700, 2139 Route 35 North Vertiflex Superion provides lasting pain relief without the risks or long recovery time of major surgery. of Dickson-Diveley Orthopaedics . This review assesses these treatment modalities to investigate the current cost-effectiveness, safety, and performance of these modalities compared with the interspinous spacer procedure. 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. Such training, which consists of both didactic and laboratory work, is offered by Vertiflex® to those interested in … Refer to the Instructions for Use provided on www.vertiflex.com for additional Indications for Use, contraindications information and potential adverse effects, warnings, and precautions prior to using this product. The surgical incision is then closed. This includes: Minimal blood loss; Reduced operating time and hospital stay; Streamlined procedure; Reduced risk of … Don’t miss this important call, so keep your phone nearby. When these factors are determined in the initial consultation, the process follows the established guidelines of the "Agency for Health Care Quality Review," a government agency that assesses new surgical procedures to determine their effectiveness and benefits for patients when compared to the risks involved. medicine, physical therapy & injections) and back surgery. You only chose "Other" for the location of your pain. The Superion™ Indirect Decompression System (IDS) is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, having radiographic evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. You will receive sedating medication through an IV, and your back is scrubbed with an antibacterial cleanser. The recovery time is short. Please enter a valid phone number with your 3-digit area code and your 7-digit telephone number. Are there risks associated with the Vertiflex Superion procedure? And, unlike a spinal fusion, it preserves the range of motion in the lower back so there is … Non-binary This minimally invasive treatment helps fill the gap between conservative care (i.e. Track your pain, learn about treatments, and generate progress reports. 4 You when you lean on something, bend forward, or sit down. What are the risks associated with Vertiflex Superion? For most people, symptoms develop gradually over time and are often made worse by standing and walking. The Vertiflex procedure won’t “loosen” the stability of the spine like a laminectomy can. What are the risks associated with Vertiflex Superion? The Solution . PILD for LSS is a posterior decompression of the lumbar spine performed under indirect image guidance without any direct visualization of the surgical area. Introduce the Vertiflex Procedure to an audience in dire need of liberation from agonizing leg and back pain and, in the process of increasing awareness, gather a tribe of true believers who will spread the word that a safe and effective solution has arrived for lumbar spinal stenosis. The Superion Interspinous Spacer may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5. See Table 1 for an overview of benefits and risks of the treatment modalities and Table 2 for a tabulation of costs associated with the treatment modalities. If lumbar spinal stenosis is left untreated, it can worsen over time, leading to excessive narrowing of the spinal canal. All rights reserved. Use our Doctor Locator to explore pain management specialists in your area. The pain … Widening the space between vertebrae relieves pressure being placed on nerves. Risks include infection, bleeding and nerve injury. This treatment is for leg and lower back pain caused by lumbar spinal stenosis. (609) 495-1888, 1200 Eagle Avenue This may be the best treatment option for patients who have failed to find relief through more conservative treatment options. There are other surgical risks as well, such as infection, a tear in the membrane that covers the spinal cord, a blood clot in a leg vein and/or neurological deterioration. In fact, Vertiflex Superion can eliminate the need for major spine surgery for many patients. Severe osteoporosis (DEXA scan or equivalent) in the spine or hip that is more than 2.5 S.D. See details highlighted below. If pain from mild to moderate spinal stenosis is keeping you from enjoying a more active lifestyle, Superion® by Vertiflex® may have a solution. 2020 Quick Reference Guide –The Vertiflex ® Procedure † Outpatient Hospital2020. †Superion™ Indirect Decompression System. The Vertiflex is a minimally invasive stand-alone interspinous process decompression (IPD) procedure. We will make every effort to contact you within the next 48 hours. Vertiflex Superion® is a new procedure for treating lumbar spinal stenosis, a common cause of lower back pain in people over 50. This drug-free therapy can provide months of safe, effective pain relief. 45-54 The Superion™ Interspinous Spacer is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without back pain, who have undergone at least 6 months of non-operative treatment. ©2021 Boston Scientific Corporation or its affiliates. Superion™ Indirect Decompression System. Oops, something isn’t right. Includes adjustment from 0 to 90 degrees with no risk to the child. Download your Doctor Discussion Guide. 7 You are 45-54 years of age and you are female. What are the risks associated with The Vertiflex Procedure? This can cause constriction of the nerves that run down the back and into the legs, resulting in pain, discomfort, and limited mobility. It is used mostly by interventional pain physicians who can also perform the minimally invasive lumbar decompression (MILD procedure). The narrowing of the space can cause pinching on the nerves in the lower back which can result in an aching, dull back pain spreading down the buttocks and into the legs. Once the Superion® device is implanted it creates more space for your spinal cord and nerves in your spinal column without removing any bone (as in a traditional laminectomy) and with less trauma to your muscles and ligaments. Female Have you been suffering from pain for more than a year? Your physician uses an X-ray camera to identify the target level, and a local anesthetic is used to numb the skin. Based on the duration of your pain, you may not qualify for one of our pain management solutions at this time. 2020 Quick Reference Guide –The Vertiflex ® Procedure † Outpatient Hospital2020. As with all procedures, there are some risks, including: The implant can become dislodged or moved out of place Download your Doctor Discussion Guide to use when you consult your pain management specialist. Generally, the procedure takes 15 to 45 minutes to perform depending on whether one or two spacers are implanted. Based on your answers, you may be a candidate for: You should consult your pain management specialist to make a final determination. In fact, Vertiflex Superion can eliminate the need for major spine surgery for many patients.