The system is designed to provide anterior spinal column support and bone graft containment to promote bony fusion. Nuvasive s xlif medtronic dlif other lateral fusion migfkfbdpx pdf subject. Maximum access surgery mas posterior fixation for the thoracolumbar spine is a minimally disruptive procedure intended to implant a pedicle screw fixation device to provide realignment. It is not meant to replace any personal conversations that you might. Lateral interbody fusion using the xlif system clinical gate. For the 7 reasons set forth on the record at the hearing and as discussed below, the motion is 8 denied. Nuva free report received an expanded 510k clearance from the fda for its tlx interbody system. In 11 2003, nuvasive launched a minimallyinvasive, lateral access surgical procedure for spinal 12 surgery, known as xlif.
The tlx interbody system is inserted through a conventional transforaminal. A system and method for spinal fusion comprising a spinal fusion implant of nonbone construction releasably coupled to an insertion instrument dimensioned to. Building on the concept and technique of minimally invasive spinal approaches, we have developed the extreme lateral interbody fusion xlif, nuvasive, inc. In addition to broad applications in spine surgery, our mas platform has enabled innovative procedures such as extreme lateral interbody fusion, or xlif, which offers advantages over other minimally invasive.
Xlif is the only lateral approach procedure proven by over 10 years of clinical evidence. Extreme lateral interbody fusion xlif is a relatively new technique whereby access to the disc space is achieved through a minimally invasive lateral, retroperitoneal, transpsoas approach. The integration of these procedures into a single system allows for significant time savings through the use of modern, less invasive techniques. Over 400 published clinical studies support the procedure. The first innovation we dived into was xlif crestline last month view the interview here, and now were showcasing modulus xlif. Nuvasive s xlif medtronic dlif other lateral fusion its immensely important to start browse the introduction section, next towards the short discussion and find out all the topic coverage on this pdf. Nuvasive acquired the lessray product from saferay spine and launched the product in 2018 as a fluoroscopy system that enhances the clarity of radiographic images. For the lateral approach, the system can be integrated with the nuvasive xlif procedure to perform singleposition surgery for multilevel cases. The mas platform enables procedures such as xlif, or extreme lateral interbody fusion, a minimally disruptive spine surgery that accesses the spine through the patients side 7. The nuvasive italy team celebrated the holiday season with numerous team building activities. It is not meant to replace any personal conversations that you might wish to have with your. Nuvasive has announced the launch the new reline trauma portfolio, which is designed to provide surgeons the flexibility to customise their approach intraoperatively, including traditional open, maximum access surgery or hybrid procedures, depending on. Our product portfolio is focused on applications in the over. The extreme lateral interbody fusion xlif technique is a minimally disruptive surgical procedure performed through the side of the body.
During the year ended december 31, 2010, it marketed product portfolio focused on applications for spine fusion surgery, including biologics. Using the alif access system for the supine approach delivers enhanced imaging and direct visualization of the spine as well as access from the lateral decubitus position. The nerves of the lumbar plexus reside within the psoas, and the technique. Xlif, lateral approach, interbody fusion, minimally invasive, spinal deformity. Pelvic bones top of each called the iliac crest preventing use of xlif for anything below l4. One of the incisions is made at the side of the waist and the other behind it. The xlif surgical technique is different, however, because it incorporates two systems developed by nuvasive. Systems and methods for spinal fusion nuvasive, inc. Fixed system largest cervical option designed for ease of use. The nuvasive precept spinal system is an advanced system that consists of a number of. Jul 0 k106 nuvasivetraditional premarket notification.
Spine system represents a true advance in the treatment of thoracolumbar pathologies. Intended use the nuvasive ap expandable xlif system is indicated for intervertebral body fusion of the spine in skeletally mature patients. For lateral entry, the lateral alif access system enables singleposition surgery for multilevel cases when integrated with the nuvasive xlif lateral lumbar interbody fusion procedure, increasing o. Pdf on mar 10, 2016, ioannis siasios md and others published extreme lateral interbody fusion xlif. The nerves of the lumbar plexus reside within the psoas, and the technique is dependent upon realtime electromyographic monitoring. A reproduced with permission from nuvasive, san diego, ca.
Lateral access is a safe and reproducible means of addressing certain spine disorders with an approach from the side of the patient, as opposed to an approach from the back posterior or the. Nuvasive says rival hired key workers, copied spine system. Nuvasive clinical services lessray advanced materials science pulse x360 procedures. Nuvasive plans to continue development on a wide variety of projects intended to broaden surgical applications for greater procedural integration of its maximum access surgery techniques and additional applications of the magnetic expansion control magec spinal bracing system technology. Nuvasive is a medical device company focusing on the design, development and marketing of products for use in minimally disruptive surgical treatments for the spine. Patients the better way back provides hope, support, and information to patients suffering from chronic back, leg, and neck pain. Carm from the anterior side of the patient to prepare for the xlif andor. They also partnered with famiglie sma, a nonprofit organization that supports patients and families affected by spinal muscular atrophy sma. The maxcess retractor system eliminates the need for traumatic tissue cutting since the surrounding tissue is dilated instead of cut. This lateral lumbar interbody fusion llif system includes insertion instruments for the interbody implant, a retractor system, table arm, and disc preparation instruments. Walked into surgery fine, no leg issues just localized back pain. They had a christmas tree decorating party and dinner to celebrate their accomplishments of 2019. The company description says this system provides procedural versatility in a compact midline construct.
The information provided is general the information provided is general coding information only. Walk with a walker short distances otherwise in a wheelchair. Nuvasives doubledigit revenue growth continues to prove that it is having success competing against established industry giants like medtronic and. Nuvasive launches reline trauma portfolio spinal news. Biomechanical analysis of cortical versus pedicle screw. In addition, the nuvasive cervical disc arthroplasty reimbursement guide is composed of information about physicianhospital coding and payment for cervical disc arthroplasty and features a pcm cervical disc description. Modulus xlif provides a differentiated offering for the nuvasive flagship xlif procedure. Precept pedicle screw system, nuvasive, inc, san diego, ca were placed along a conventional lateraltomedial trajectory. Heres why nuvasive is tanking today the motley fool. During an xlif procedure, the patient is placed on their side and two tiny incisions are made. The xlif technique is a minimally disruptive surgical procedure performed through the side of the body.
The nuvasive nvm5 intraoperative monitoring iom reimbursement guide contains pertinent information and scenario examples regarding iom coding and payment. Over 400 published clinical studies support the procedure, documenting positive clinical. Neurovision, a proprietary softwaredriven nerve avoidance system. Nuvasive introduces alif retractor for lateral, supine. The better way back spinetrack registry reach your height find a surgeon surgeons nuvasive is committed to continued. Over 400 published clinical studies support the procedure, documenting positive clinical outcomes such as reduced blood loss, less time in the o.
Leveraging thoughtful design principles crucial to successful anterior lumbar fusion, we have designed each instrument and implant to help enhance safety. Although anticipated pros of mis xlif included reduced blood loss. Spine extreme lateral interbody fusion xlif neurodiagnostics. We are a medical device company focused on the design, development, and marketing of products. The next evolution of the reline system nuvasive has just launched. Nuvasives tlx interbody system gets expanded fda approval. Nuvasive launch their next generation reline system. As such, it forms a big part of different fixation techniques of the spine. Mas combines three categories of nuvasives current product offerings. About us we use cookies to optimize site functionality and give you the best possible experience.
Surgical outcome and related complications in an academic center. Nuva introduced a new implant to be used with its xlif spinal fusion procedure in the u. From complex spinal deformity to degenerative spinal conditions, nuvasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. It is designed to treat a range of spinal pathologies. Nuvasive launches brigade lateral orthopedics this week. Precept pedicle screw system were placed using a medialtolateral technique. Nuvasivetraditional 5 10k premarket notification nu vasiveo ap expandable xlif system e. Nuvasive allograft biologic which contains all 3 properties for bone growth oc cancellous bone chips. Lateral interbody fusion xlif corpectomy surgical procedure. Nuvasive launches retractor for lateral, supine approaches. Resources nuvasive is dedicated to providing continued support and resources to patients and surgeons from preop to postop. Nuvasive is a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurallyintegrated solutions. Nuvasive is a world leader in minimally invasive, procedurally integrated spine solutions. The expedium spine system incorporates techniquesimplifying designs, including a state of the art internal closure mechanism and a comprehensive set of implants designed in harmony with the instruments.
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