Transport unit dimensions. The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. Common performed techniques include Superion Vertiflex and Vertos Minimally Invasive Spine Decompression (MILD procedure). Vertiflex has developed a new system for treating spinal stenosis called the Totalis Direct Decompression System. TEL: +1 949 723 9309 Totalis utilizes the VertiFlex proprietary interspinous access platform to treat spinal conditions such as lumbar stenosis. 470 x 670 x 500 mm Custom size on request. Advertising: Michael Broughton [emailprotected], United Kingdom: Despite the lack of coverage for PILD procedures, patients enrolled in the approved CED clinical study for VertiFlex's Totalis Direct Decompression System will be able to receive Medicare coverage for the procedure. Site Map | Privacy Policy | RSS, LivaNova taps the miracle nerve to combat epilepsy; How hospital workforce shortages hit Medtech. The device is made of titanium and is designed to be placed between the spinous processes (the bumps you can feel under your skin) to help make more room for the nerves which are affected by your spinal stenosis. Totalis utilizes the. VertiFlex has announced it has received FDA clearance of two new products: the Totalis direct decompression system and UniVise spinous process fixation system. Numbness, weakness, cramping, or stiffness in the legs or buttocks. Talk with your doctor and family members or friends about deciding to join a study. The Totalis system was 510 (k) cleared by the FDA in November, 2012. Purpose: The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis Setting the Standard of Care for Lumbar Spinal Stenosis (LSS) The Vertiflex Procedure is redefining the treatment of LSS for patients. This provides new options for interventional spine physicians and less invasive options for traditional spine surgeons to treat patients who would otherwise undergo more invasive surgery. CMS has decided to extend coverage to patients in the investigational trial. The procedure is performed through the VertiFlex proprietary interspinous access platform utilizing a small working cannula about the size of a dime. The procedure involves a small single midline incision and sequential dilation to a working cannula about the size of a dime. Specialty instruments designed for precision and safety are then used to remove the targeted tissue. San Clemente, Calif.-based Vertiflex announced FDA clearances for its Totalis Direct Decompression System and UniVise Spinous Process Fixation System. See all Peripheral Artery and Vein interventions, See all Spinal Cord Stimulator (SCS) systems device support, Update on LOTUS Edge Aortic Valve System, See all Transcatheter Aortic Valve Replacement device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions. It is used mostly by interventional pain physicians who can also perform the minimally invasive lumbar decompression (MILD procedure). The UniVise Spinous Process Fixation System is a spinal implant system designed to provide fixation of the spinous processes as an adjunct to lumbar spinal fusion. Superion is the most advanced, least invasive and currently the only ISS available or in development. This broad decompression involves minimal collateral tissue disruption and can be performed under local anaesthesia. . The Email: [emailprotected] The implant holds the vertebrae open, relieving pressure on the nerves in the spinal canal. The system utilizes VertiFlex proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal conditions such as lumbar stenosis. United States: One each from columns A and B. 3. single to multi-deep. Contraindications, warnings, precautions, side effects. Why Should I Register and Submit Results? Load weight per transport unit. The STEPS - Totalis Trial Latest version (submitted August 4, 2020) on ClinicalTrials.gov A study version is represented by a row in the table. This Level 1 evidence-based procedure is supported by data from patients who reported successful outcomes up to five years. The procedure is performed through the VertiFlex proprietary interspinous access platform utilizing a small working cannula about the size of a dime. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights. Specialty instruments designed for precision and safety are then used to remove the targeted tissue. Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH. These technologies fill the MIS procedural gap in the stenosis treatment continuum between conservative care and traditional spine surgery. 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. 200 x 200 x 50 mm, max. 155 North Wacker Drive, Suite 4250, Chicago, IL 60606 The Totalis Direct Decompression System was 510 (k) cleared by the FDA in November 2012. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Integrated Pain Management Medical Group, Inc. Walnut Creek, California, United States, 94598, Washington, District of Columbia, United States, 20037, Fort Lauderdale, Florida, United States, 33334, Merritt Island, Florida, United States, 32953, Stockbridge, Georgia, United States, 30281, Independence, Missouri, United States, 64055, Somerset, New Jersey, United States, 08773, Oklahoma City, Oklahoma, United States, 73120, Hershey, Pennsylvania, United States, 17033, Performance Spine and Sports Physicians, PC, Pottstown, Pennsylvania, United States, 19464, Murrells Inlet, South Carolina, United States, 29576, Percentage of Subjects With Clinically Significant Improvement in Outcomes [TimeFrame:Baseline and 6 Months], Improvement in physical function by 0.5 points from baseline, Improvement in symptom severity by 0.5 points from baseline, Patient Satisfaction Score of < 2.5 points, Re-operations or revisions at index level(s) intended to treat stenosis, Epidural steroid injection or selective nerve root block at index level(s), Male or female subjects greater than or equal to 55 years of age, Neurogenic intermittent claudication (NIC) symptoms defined generally as leg/buttock/ groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion, VAS leg symptom severity >50 (in either leg) during episodes of neurogenic claudication, Subjects who are able to walk a minimum of 50 feet without experiencing NIC symptoms, Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, at one or two levels from L1-L5 with radiologic evidence, Subjects with persistent lumbar spinal stenosis symptoms that, during the course of the last year, have been unresponsive to a minimum of 6 months of conservative therapy, Significant back, buttock or leg pain from causes other than lumbar central canal stenosis, Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level, Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention, Prior decompressive surgery at index level (s) or fusion at any lumbar level, Epidural steroid or nerve block steroid injection at index level(s) within 6 weeks of baseline assessments, Spondylolisthesis (anterolisthesis or retrolisthesis) greater than grade 1, Significant degenerative lumbar scoliosis at index level(s), Undergoing immunosuppressive therapy or long-term steroid use, Current spinal cord stimulator or implanted pain pump, Evidence of substance abuse within the year, Involvement or potential involvement in litigation related to the spine or worker's compensation related to a back and/or leg issue. Announces First Patient Successfully Treated with the Totalis Direct Decompression System Vertiflex, Inc. The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. Listing a study does not mean it has been evaluated by the U.S. Federal Government. VertiFlex Inc., a medical device company, develops minimally invasive solutions for the treatment of lumbar spinal stenosis (LSS). For general information, Learn About Clinical Studies. We are committed to providing the least invasive treatments while providing the greatest benefits for our patients. The procedure provides physicians the ability to remove ligament, bone, and facet capsule material to address both central and lateral recess stenosis. Subscribe to Medical Design & Outsourcing. See all Peripheral Artery and Vein interventions, See all Spinal Cord Stimulator (SCS) systems device support, Update on LOTUS Edge Aortic Valve System, See all Transcatheter Aortic Valve Replacement device support, Indications for Use, Precautions and other Safety Information, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions. . This broad decompression involves minimal collateral tissue disruption and can be performed under local anaesthesia. boston scientific corporation (nyse: bsx) today announced the close of its acquisition of vertiflex, inc., a privately-held company that developed and commercialized the superion indirect decompression system, a minimally-invasive device used to improve physical function and reduce pain in patients with lumbar spinal stenosis (lss) - the Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. Varithena polidocanol injectable foam 1% varicose vein treatment. The Superion Indirect Decompression System is a simple procedure that should only be performed by physicians who have received adequate training. Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis. You have been diagnosed with lumbar spinal stenosis. This is "Totalis Direct Decompression System" by Informa Publications on Vimeo, the home for high quality videos and the people who love them. The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis Court Empey and Spencer Wells of Desert Pain Specialists are pleased to announce they are now providers of Vertiflex's Superion Indirect Decompression System, a new treatment . The Superion Indirect Decompression System (IDS) is contraindicated for patients who: have spinal anatomy that prevent implantation of . THE RESULTS ARE CLEAR The most extensive device clinical trial on lumbar spinal stenosis. Medici Spine & Pain welcomes patients from in or around Georgia to book a Vertiflex consultation. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079038. Under this decision, Medicare coverage for the VertiFlex Totalis Direct Decompression System will be available for beneficiaries with lumbar spinal stenosis (LSS) who are enrolled in an approved CED clinical study. The system utilizes VertiFlex' proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal stenosis by removing . Terms and Conditions | Privacy Policy, AR has the potential to improve workflow for minimally invasive transforaminal lumbar interbody fusion, SeaSpine announces full commercial launch of the Mariner MIS Wayfinder system, Life Spine announces first surgical cases of the ProLift micro endoscopic expandable spacer system, Stryker receives FDA clearance for OptaBlate bone tumour ablation system. Call Us: 206-690-6790 Request an Appointment How is the procedure done? Where clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ). Key Features of the Vertiflex Superion System Include: One piece . The Totalis Direct Decompression System was 510(k) cleared by the FDA in November, 2012. 2022 Boston Scientific Corporation or its affiliates. min. 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 To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. The Vertiflex procedure gives the spinal cord and its associated nerves space and relieves the symptoms of lumbar spinal stenosis. The Totalis system allows a more thorough resection of the offending ligament than other minimally invasive options, and still leaves the structural elements of the lumbar spine intact. The company also makes the Totalis Direct Decompression system, which performs . Totalis utilizes the VertiFlex proprietary interspinous access platform to treat spinal conditions such as lumbar stenosis. The company believes it has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis. Becker's Healthcare: Hospital; ASC; Spine; Clinical; Health IT; CFO; Dental + DSO; Payer; Podcasts; Career Center 1.800.417.2035 . References The Totalis Direct Decompression System is a unique set of surgical instruments designed to perform minimally invasive decompression of the lumbar spine. These procedures are intended to provide additional space for nerves compressed by spinal stenosis. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives. up to 35 kg, standard application, up to 50 kg, with reduced dynamics. This device is jammed between the spinous processes to force flex the vertebral segment. . . This broad decompression involves minimal collateral tissue disruption and can be performed under local anesthesia. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. from -30C to 50C (-22F to 122F) Technical Data. 2022 Boston Scientific Corporation or its affiliates. Study Title: A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex Totalis Direct Decompression System versus a Sham Surgical Procedure in Patients with Lumbar Spinal Stenosis Sponsor: VertiFlex, Inc. Clinicaltrials.gov Number: NCT02079038 CMS Approval Date: 05/22/2014 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. Editor: Anthony Strzalek [emailprotected] Email: [emailprotected] This Level 1 evidence-based procedure is supported by data from patients who reported successful outcomes up to five years. Please remove one or more studies before adding more. The procedure involves a small working cannula about the size of a . Bookmark, share and interact with the leading medical design engineering magazine today. FEATURE - Drs. MedTech 100 is a financial index calculated using the BIG100 companies covered in BIBA Medical, North America During the procedure, the patient lies face down on their stomach, and the surgeon will numb the area with general anesthesia. 4. The system utilizes VertiFlex' proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal conditions such as . The Vertiflex Procedure is a minimally invasive outpatient procedure that is done by placing a small implant, the Superion, inside the spine. It offers Superion Interspinous Spacer, a motion-preserving, indirect decompression spinal implant system for the treatment of moderate lumbar spinal stenosis. The Totalis system allows a more thorough resection of the offending ligament than other minimally invasive options, and still leaves the structural elements of the lumbar spine intact. By admin-demo The Vertiflex Procedure uses the Superion TM Indirect Decompression System, which is a small interspinous spacer designed to lift pressure off the nerves in the lower back, helping to minimize or eliminate the symptoms of leg and back pain due to LSS. For patients, it means the likelihood of greater pain relief and faster recovery. One of our biggest challenges in treating spinal stenosis is removal of the ligament which causes narrowing of the spinal canal, without further destabilizing the spine, commented Dr. Grigsby. ClinicalTrials.gov Identifier: NCT02079038 VertiFlex, Incorporated 7 August 2020. The Vertiflex interspinous spacer is an implant that is placed between the vertebrae through a small tube the size of a dime. DeviceTalks is a conversation among medical technology leaders. Brief Summary: The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis Patients included in the clinical investigation will return for follow-up visits at 1 week for safety evaluation, and at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months post-treatment to collect data for evaluation of safety and effectiveness. The Vertiflex Procedure is a minimally invasive solution that may help you find relief from leg and back pain caused by lumbar spinal stenosis (LSS). The system leverages the company's core technology and intellectual property. CMS has decided to extend coverage to patients in the investigational trial. Setting the Standard of Care for Lumbar Spinal Stenosis (LSS) The Vertiflex Procedure is redefining the treatment of LSS for patients. The procedure provides physicians the ability to remove ligament, bone, and facet capsule material to address both central and lateral recess stenosis. The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. Read our, ClinicalTrials.gov Identifier: NCT02079038, Interventional Select two study versions to compare. The Totalis Direct Decompression System is a unique set of surgical instruments designed to perform minimally invasive decompression of the lumbar spine. The Medical Device Business Journal. And no interventions of the following nature through 6 months: Choosing to participate in a study is an important personal decision. The procedure involves a small working cannula about the size of a . Founded in 2005 and headquartered in San Clemente, CA, VertiFlex has developed a proprietary, minimally invasive interspinous access platform for performing both indirect and direct decompressions of the lumbar spine. BIBA Medical, Europe526 Fulham Road, Fulham, London, SW6 5NR You have reached the maximum number of saved studies (100). The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. and claudicatory symptoms, at 6 months following treatment with the Totalis Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis Full Title of Study: "A Prospective, Multi-center, . According to a company press release, the Totalis direct decompression system is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. Direct decompression typically involves removing the structure which is compressing the nerves. Its a very significant advancement in the treatment of spinal stenosis, and the evolution of minimally invasive spinal surgery overall. About VertiFlex, Inc. VertiFlex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Copyright 2022 WTWH Media, LLC. The use of the Vertiflex interspinous spacer is a recent minimal invasive procedure useful in the treatment of lumbar spinal stenosis (LSS). The procedure provides physicians the ability to remove ligament, bone, and facet capsule material to address both central and lateral recess stenosis. Announces Sale of Non-Core Spinal Implant Technologies to Stryker Vertiflex, Inc. Completes Enrollment for the Superion Pivotal IDE Clinical Trial Doctors Test Devices to Treat Failing Discs in Lower Spine Subjects suffering from symptoms of neurogenic intermittent claudication secondary to a radiographically-confirmed diagnosis of central canal stenosis, with or without mild or moderate lateral recess stenosis, at one or two levels from L1 to L5 who meet all inclusion/exclusion criteria, including 6 months of non-operative management. Clin Interv Aging. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Post count: 8423 #27318 This is a typical interspinous flexion device like the "X-stop" among others. VertiFlex won reimbursement coverage from the Centers for Medicare & Medicaid Services for the company's Totalis direct decompression system for treatment of spinal stenosis. The system utilizes VertiFlex' proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal stenosis by removing . Study Title: A Prospective, Multi-center, Randomized Controlled Double-Blind Trial Evaluating the VertiFlex Totalis Direct Decompression System versus a Sham Surgical Procedure in Patients with Lumbar Spinal Stenosis Sponsor: VertiFlex, Inc. Clinicaltrials.gov Number: NCT02079038 CMS Approval Date: 05/22/2014 We are very pleased with the development of Totalis and the achievement of its successful first surgery, said Earl R. Fender, President and Chief Executive Officer of VertiFlex, Inc. The procedure offers the best of both worlds in that it enables spine clinicians the ability to safely perform broad lumbar decompressions in a minimally invasive approach. 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