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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. Editor: Anthony Strzalek [emailprotected]
The Vertiflex Superion Interspinous Spacer (ISS) is a motion-preserving, indirect decompression spinal implant system for the treatment of moderate lumbar spinal stenosis. Where clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ). You have been diagnosed with lumbar spinal stenosis. Bookmark, share and interact with the leading medical design engineering magazine today. The system utilizes VertiFlex' proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal stenosis by removing . CMS has decided to extend coverage to patients in the investigational trial. 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, . The system utilizes VertiFlex' proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal stenosis by removing . The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. The company's technology offers an indirect decompression system which fills the gap in the stenosis treatment continuum between conservative care and traditional spine surgery, enabling patients to get access improved treatment for lumbar stenosis through minimal tissue trauma. 2017;12:1409-1417. 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. Contact Information Website www.vertiflex.com Formerly Known As Key Features of the Vertiflex Superion System Include: One piece . It offers Superion Interspinous Spacer, a motion-preserving, indirect decompression spinal implant system for the treatment of moderate lumbar spinal 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. Vertiflex, Inc. 470 x 670 x 500 mm Custom size on request. 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 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. The Superion Indirect Decompression System (Vertiflex) was developed to treat patients with symptomatic moderate lumbar spinal stenosis. 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 This is "Totalis Direct Decompression System" by Informa Publications on Vimeo, the home for high quality videos and the people who love them. The Study . 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. The Totalis Direct Decompression System was 510(k) cleared by the FDA in November, 2012. Advertising: Michael Broughton [emailprotected], United Kingdom:
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 material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. The procedure provides physicians the ability to remove ligament, bone, and facet capsule material to address both central and lateral recess stenosis. Becker's Healthcare: Hospital; ASC; Spine; Clinical; Health IT; CFO; Dental + DSO; Payer; Podcasts; Career Center 1.800.417.2035 . 10 medical device startups you need to know, Researchers develop at-home device to track Parkinsons progression, Senators seek post-market FDA study of pulse oximeters and skin color, Connected device design for the real world: Managing the development process. Load weight per transport unit. Setting the Standard of Care for Lumbar Spinal Stenosis (LSS) The Vertiflex Procedure is redefining the treatment of LSS for patients. Setting the Standard of Care for Lumbar Spinal Stenosis (LSS) The Vertiflex Procedure is redefining the treatment of LSS for patients. Sponsors: Lead Sponsor: VertiFlex, Incorporated Source: VertiFlex, Incorporated 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 . 2022 Boston Scientific Corporation or its affiliates. Its a very significant advancement in the treatment of spinal stenosis, and the evolution of minimally invasive spinal surgery overall., Write to us
VertiFlex has announced it has received FDA clearance of two new products: the Totalis direct decompression system and UniVise spinous process fixation system.
The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine.
It's events, podcasts, webinars and one-on-one exchanges of ideas & insights. 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. VertiFlex announced that the first patients have received treatment in a trial to evaluate the VertiFlex Totalis direct decompression system for the treatment of lumbar spinal stenosis. Call Us: 206-690-6790 Request an Appointment How is the procedure done? The system leverages the company's core technology and intellectual property. 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. 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). Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis. The procedure involves a small single midline incision and sequential dilation to a working cannula about the size of a dime. Nunley PD, Patel VV, Orndorff DG, Lavelle WF, Block JE, Geisler FH. NASS 2022: Robotic and navigational assistance is cost-effective for minimally-invasive adult DePuy Synthes receives FDA clearance for TELIGEN system, Spinal News Internationals top 10 most popular stories of October 2022, Spinal News Internationals top 10 most popular stories of September 2022, Spinal News Internationals top 10 most popular stories of August 2022. from -30C to 50C (-22F to 122F) Technical Data. 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 Transport unit dimensions. min. The system utilizes VertiFlex proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal conditions such as lumbar stenosis. This broad decompression involves minimal collateral tissue disruption and can be performed under local anaesthesia. There now exists a pathway for reimbursement for PILD procedures and Totalis for Medicare beneficiaries. San. Principal Investigator: Vertiflex Totalis STEPS Trial: 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. This broad decompression involves minimal collateral tissue disruption and can be performed under local anaesthesia. FEATURE - Drs. Email: [emailprotected]
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The Vertiflex procedure gives the spinal cord and its associated nerves space and relieves the symptoms of lumbar spinal stenosis. Listing a study does not mean it has been evaluated by the U.S. Federal Government. The Totalis Direct Decompression System is a unique set of surgical instruments designed specifically for performing minimally invasive direct decompressions of the lumbar spine. 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 . TEL: +1 949 723 9309
The company believes it has compiled the largest, most rigorous, body of device clinical evidence, related to lumbar spinal stenosis. Please remove one or more studies before adding more. Information provided by (Responsible Party): 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. The Totalis Direct Decompression System is a unique set of surgical instruments designed to perform minimally invasive decompression of the lumbar spine. 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 The use of the Vertiflex interspinous spacer is a recent minimal invasive procedure useful in the treatment of lumbar spinal stenosis (LSS). 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 VertiFlex Inc., a medical device company, develops minimally invasive solutions for the treatment of lumbar spinal stenosis (LSS). The system utilizes VertiFlex ' proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal conditions such as . The company also makes the Totalis Direct Decompression system, which performs . Flexion causes the canal to open up (see https://neckandback.com/conditions/lumbar-spinal-stenosis-central-stenosis/ to understand this process. The Medical Device Business Journal. VertiFlex has announced it has received FDA 510(k) clearance for the Totalis direct decompression system and the UniVis spinous process fixation system.
SAN CLEMENTE, Calif.(BUSINESS WIRE)Mar 18, 2013VertiFlex, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies , today announced successful completion of the first Totalis Direct Decompression procedure, performed by Dr. Eric Grigsby at the Napa Surgery Center on March 1, 2013. This Level 1 evidence-based procedure is supported by data from patients who reported successful outcomes up to five years. 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. Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The
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 Vertiflex interspinous spacer is an implant that is placed between the vertebrae through a small tube the size of a dime. up to 35 kg, standard application, up to 50 kg, with reduced dynamics. The company also provides Totalis Direct Decompression System specialized instruments to safely perform . 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. San Clemente-based VertiFlex Inc. has raised $15.2 million from six investors, according to filings with the SEC. The Superion Indirect Decompression System (IDS) is contraindicated for patients who: have spinal anatomy that prevent implantation of . This system involves very small tools and enables doctors to operate through a small incision in the back. La Ciotat (French: ; Provenal Occitan: La Ciutat [la sjewta]; in Mistralian spelling La Ciutat; 'the City') is a commune in the Bouches-du-Rhne department in the Provence-Alpes-Cte d'Azur region in Southern France.It is the southeasternmost commune of the Aix-Marseille-Provence Metropolis.La Ciotat is located at about 25 km (15.5 mi) to the east of Marseille, at an equal distance . Varithena polidocanol injectable foam 1% varicose vein treatment. 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. Read our, ClinicalTrials.gov Identifier: NCT02079038, Interventional
References: The procedure involves a small working cannula about the size of a . Totalis utilizes the VertiFlex proprietary interspinous access platform to treat spinal conditions such as lumbar stenosis. All Rights Reserved. MedTech 100 is a financial index calculated using the BIG100 companies covered in
Read more about the Vertiflex Procedure MRI Compatibility. Why Should I Register and Submit Results? The Totalis Direct Decompression System was 510 (k) cleared by the FDA in November 2012. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 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. The system utilizes VertiFlex' proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal conditions such as . You have reached the maximum number of saved studies (100). 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 Specialty instruments designed for precision and safety are then used to remove the targeted tissue. 3. 1. Email: [emailprotected]
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. 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. When the implant is placed, it has arms or projections, which open and surround the . The system uses VertiFlexs proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal conditions such as lumbar stenosis. 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. One each from columns A and B. . Specialty instruments designed for precision and safety are then used to remove the targeted tissue. The system utilizes VertiFlex' proprietary interspinous access platform and includes both reusable and disposable instruments to treat spinal stenosis by removing . For general information, Learn About Clinical Studies. These technologies fill the MIS procedural gap in the stenosis treatment continuum between conservative care and traditional spine surgery. Storage density. The Totalis system was 510(k) cleared by the FDA in November, 2012. 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. 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. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079038. The Totalis Direct Decompression System is a unique set of surgical instruments designed to perform minimally invasive decompression of the lumbar spine. 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. VertiFlex, Incorporated 7 August 2020. 200 x 200 x 50 mm, max. 4. 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. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives. San Clemente, Calif.-based Vertiflex announced FDA clearances for its Totalis Direct Decompression System and UniVise Spinous Process Fixation System. Setting the Standard of Care for Lumbar Spinal Stenosis (LSS) The Vertiflex Procedure is redefining the treatment of LSS for patients. Compared to the standard spinal decompression procedure, this affects a smaller portion of tissues. VertiFlex has announced that Eric Grigsby, Napa Surgery Center, USA, has successfully treated the first patient with the Totalis direct decompression system. The implant holds the vertebrae open, relieving pressure on the nerves in the spinal canal. Numbness, weakness, cramping, or stiffness in the legs or buttocks. 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