vertiflex clinical trial

Contraindications. The Vertiflex procedure uses a small implant that is designed to treat LSS. Announces Sale of Non-Core Spinal Implant Technologies to Stryker. Avoid strenuous activity for 6 weeks after surgery, contact your physician if there is fluid leaking from your incision, if you have pain, swelling or numbness in your legs or buttocks or if you fall. . (410) 825-6945 The Vertiflex Procedure was the subject of an extremely thorough FDA clinical trial for LSS. Available 5 AM to 5 PM PT, Monday through Friday, To speak with Pain Education Specialist, call 1.866.360.4747, Available 5 AM to 5 PM PT, Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04192591. Clinicaltrials.gov Number: NCT02093520 The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. Guided using real-time x-ray, a small tube about the size of a dime, also called a dilator, is used . Sponsor: Vertos Medical Official websites use .govA The Vertiflex Procedure offers a safe and effective alternative to more invasive surgical options, with most people returning home the same day they receive the Vertiflex Procedure. This is a procedure proposed as a treatment for symptomatic LSS unresponsive to conservative therapy. The spacer preserves the space in the spine, which keeps pressure off the nerves that cause leg and back pain. This indirect spine decompression procedure reduces or resolves pain for 90% of patients. All fields must be completed to submit the form. The Vertiflex Procedure is currently being offered at select US centers through a new clinical research study called the SCOPE Study. Is really painful walking. Subject signed a valid, IRB-approved informed consent form (ICF) provided in English. Its minimally invasive approach is preferred among many doctors across the United States. This is mostly due to the fact it is a minimally-invasive procedure. Vertiflex superion is a spacer, inserted into the spine, that helps preserve normal movement. For appropriate guidance, consult the instructions for use for these active devices. Indications for Use: The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. The spacer is designed to support your existing anatomy and does not require removal of bone, making it a safe option for LSS treatment. The Vertiflex procedure is performed on an outpatient basis. I have another three weeks to gol I will be happy to keep corresponding with you and giving up-dates. Vertiflex A1-A2-A3. For complete indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747 or visit Pain.com. The system can be used as a guillotine window in hotel glazing, caf glazing, restaurant glazing, balcony glazing, stadium glazing, marine glazing, etc. The Vertiflex Procedure is a minimally invasive treatment for lumbar spinal stenosis. With approximately $400 million in committed capital, H.I.G. Map & Directions, The Spine Institute of UM St. Joseph Medical Center office Able to independently read and complete all questionnaires and assessments provided in English. A federal government website managed and paid for by the U.S. Centers for Medicare & Medicaid Services. The implant is carefully placed between the affected vertebrae to hold them open. MMWR Morb Mortal Wkly Rep 2018;67:10011006. Mon - Thu. You should speak to a pain management specialist before making a determination about any therapies or procedures. 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 spacer preserves the space in the spine, which keeps pressure off the nerves that cause leg and back pain. The NCD that requires a prospective longitudinal study design is available on our website at /medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=284. Results from the trial proved the effectiveness of the procedure, with significant improvement in pain relief. ClinicalTrials.gov Identifier: NCT04192591, Interventional You should consult your pain management specialist to determine what treatments are right for you. Results from the trial proved the effectiveness of the procedure, with significant improvement in pain relief, overall results may vary. You'll want one in every room. Contacts. 1 You have been suffering from pain for . The implant may successfully provide patients suffering from chronic back and leg pain with sustainable relief. The Vertiflex Procedure is intended to provide the same relief you experience when leaning forward or sitting down. Male The Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant. It is implanted minimally invasively through a cannula designed to be less traumatic to the patient. (Superion , VertiFlex, Inc.) . (888) 261-7506 Vertiflex This video is private SCHEDULE APPOINTMENT Designed for Patient Comfort & Safety Patients no longer have to choose between conservative methods and invasive surgery to treat lumbar spinal stenosis. All my patients have been 65+, my oldest was 93. The procedure is as follows. It has been so hot, so I have not been able to walk too much, but I think my walking is improving. It uses a small, titanium alloy spacer which serves as an extension blocker designed to relieve pressure on the affected nerves. It is reversible. Clinically Proven for LSS 1 The Vertiflex Procedure underwent one of the most rigorous studies on Lumbar Spinal Stenosis. Learn about the different pain relief solutions we offer and which one may be right for you. Medical records research uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best. Fri. 8:00 AM - 2:00 PM. Boston Scientific offers solutions to help manage pain experienced in the back, neck, shoulders, legs, or lower limbs. lock Based on your pain score, you may not be qualified for one of our pain management solutions at this time. The Vertiflex Procedure is a safe, minimally invasive treatment that has been clinically proven to provide effective long-term relief from the pain associated with LSS. means youve safely connected to the .gov website. An official website of the United States government The Precision Montage MRI, WaveWriter Alpha and WaveWriter Alpha Prime SCS Systems with ImageReady MRI Full Body Technology are MR Conditional only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady MRI Full Body Guidelines for Precision Montage MRI or WaveWriter Alpha and WaveWriter Alpha Prime Spinal Cord Stimulator Systems. Female The Spinal Cord Stimulator system may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Is Vertiflex right for you? Vertiflex is an implant that fits between your vertebral bones. Now that you know more about the options available to you, let our specialists guide you on your next step. 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 was the subject of an extremely thorough FDA clinical trial for LSS. The Vertiflex procedure gives the spinal cord and its associated nerves space and relieves the symptoms of lumbar spinal stenosis. The Vertiflex device is a safe and effective treatment ideal for treating lumbar spinal stenosis. It has helped some maybe 25% Now after 5 months I'm experiencing a pulling from my buttocks down the back of my legs. Vertiflex provides patients with a clinically proven . Clinical Trial Issues - Confounders including . A small spacer is placed inside the spine without removal of any nearby bone or tissue. Since FDA approval, more than 20,000 patients have received pain relief through the procedure. Fender also said the company has enrolled the "largest-ever" clinical trial for pre-market approval from the FDA of a device to treat spinal stenosis. This means there's only a small incision, so you have less pain and faster healing time compared with . .gov Direct medical care costs were modeled from 2014 Medicare reimbursements for healthcare services. 7 You are 45-54 years of age and you are female. Once inserted, the spacers arms open around the spinous processes (the bumps you can feel in your spine) to help make proper space for the affected nerves. The Vertiflex implant is a small device made of titanium that can widen the spinal canal. For patients with moderate LSS, the Vertiflex Procedure is designed to provide clinically proven, long-term relief. Relieving pressure helps to reduce tissue damage and blood loss, and thus pain. leg, or lower limb pain. The Vertiflex Procedure is supported by a rigorous body of clinical evidence demonstrating its safety and efficacy: prospective, randomized, controlled, multicenter trial with 470 patients at 29 sites; plus, a 24-month follow-up and annually thereafter through 60 months. 45-54 The spacer can be removed if you need more invasive surgery. Map & Directions, University of Maryland St. Joseph Medical Center Prevalence of Chronic Pain and High-Impact Chronic Pain Among Adults United States, 2016. Information provided by (Responsible Party): To compile real-world outcomes of the Superion IDS in routine clinical practice. Additional symptoms may include leg numbness, weakness, and decreased physical endurance. Based on the duration of your pain, you don't qualify for one of our pain management solutions at this time. See details highlighted below. If you are suffering from lower back and leg pain, it is best to visit us to receive an effective solution to your problem. The implant is placed between the spinous discs and helps to hold them open, which may alleviate that narrowing that is pinching your nerves. A tiny, inch incision is made at the site of the insertion. 2017;20(6):589-599. Browse our extensive collection and support resources to find the answers you need. The system should not be charged while sleeping. The Vertiflex Procedure was the subject of an extremely thorough FDA clinical trial for LSS. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the VertiFlex recently won FDA clearance for 2 . website belongs to an official government organization in the United States. Once you sit down the spine opens up and the pain goes away. Thomson SJ, Kruglov D, Duarte RV. LSS Patient Types Lumbar Spinal Stenosis (LSS): Central, Lateral and Foraminal Real-World Outcomes Learn more from patients who use these technologies and see how well they work. Oops, something isnt right. The use of the Vertiflex interspinous spacer is a recent minimal invasive procedure useful in the treatment of lumbar spinal stenosis (LSS). Clinical Data The lever is flipped down to lock the implant into place. Has anyone else experienced this and if so, do you find anything to help it. 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. Leaning over a cart while walking also relieves the pain. The Vertiflex proceduremay help restore the natural space your nerves need to provide relief from your symptoms. Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. The patient lays face down on the operation table. subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. Vertiflex, Inc. Completes Enrollment for the Superion Pivotal IDE Clinical Trial. The physician uses a local anesthetic to numb the lumbar region and then makes a dime-sized incision in the back. The Vertiflex Procedure helps minimize the effects of spinal degeneration while fully preserving the patient's anatomy. If youve struggled with chronic low back and/or leg pain for at least 6 months that has not responded to other treatments, you may be a candidate for the FAST Study. Neuromodulation. Have you been suffering from pain for more than 6 months? The functional design of the vertiflex lines allows for . finalize a robust clinical trial protocol." "This comes at an exciting time for VertiFlex, as all 24 month follow up in our Superion Interspinous Spacer IDE Trial has just completed, and we are preparing to submit our PMA shortly," said Fender. This level-one evidence-based procedure is supported by data from patients who reported successful outcomes up to five years. The device is available in multiple sizes for a variety of body . Vertiflex Procedure Call (703) 520-1031 or use the form below to send us your contacts. Stimulation must be turned off first in such cases. https:// The Vertiflex Procedure was developed with patient safety and comfort in mind. Based on the pain area(s) chosen, you may not be qualified for one of our pain management solutions at this time. This spacer helps relieve the pressure that is placed on nerves compressed by spinal canal narrowing. As part of CED, we are identifying below the Medicare approved clinical trials which have been reviewed and determined to meet the requirements of coverage. The Vertiflex Procedure was the subject of an extremely thorough FDA clinical trial for LSS. Proportion of subjects with VertiFlex Patient Satisfaction Survey scoring 3 on a 4-point scale 45 years of age or older when written informed consent is obtained Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart). If youve been living with dull or aching leg pain, numbness or cramping (with or without back pain), you may have lumbar spinal stenosis (LSS) - and you have options. It's a procedure where specially designed implants are placed between vertebral joints. health of patients around the world. The Superion Indirect Decompression System (Vertiflex) was developed to treat patients with symptomatic moderate lumbar spinal stenosis. Because it is a minimally-invasive procedure, the Vertiflex procedure is a solution for back pain patients for whom medications or injections have failed. The Vertiflex Procedure is a safe, minimally invasive treatment that has been clinically proven to provide effective long-term relief from the pain associated withlumbar spinal stenosis (LSS). This procedure uses a small spacer that is placed inside the spine without impacting the nearby bone or tissue. 310-574-2777 Schedule a Consultation BOOK NOW CONTACT US Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. . Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. This treatment is for leg and lower back pain caused by lumbar spinal stenosis. 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