… NuVasive is a world leader in minimally invasive, procedurally integrated spine solutions. 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. The surgical technique provides surgeon partners reproducible results and increased O.R. Pedicle Targeting 6 3. Together we make NuVasive a leader in the spine industry with our unique focus on Speed of Innovation¬. This evolution took us back to the drawing board to design a more comprehensive system to answer these demands. Due to the obesity and deep surgical field, the patient had expected blood loss. Nuvasive Annual Report 2021 Form 10-K (NASDAQ:NUVA) Published: February 25th, 2021 PDF generated by stocklight.com . External Messages • Accommodates various surgical situations through a wide variety of implant options Reline 3D, which is an extension to the NuVasive’s Reline system, is part of the firm’s comprehensive spine fixation portfolio that includes Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. and deep surgical field, the patient had expected blood loss. For Percutaneous Techniques: Utilizing a percutaneous approach, make an appropriate skin incision. PathFinder NXT® Minimally Invasive Pedicle Screw System—Surgical Technique Guide 11 STEP 12 • Set the PAT T-handle to the “non-ratcheting” position and re-attach it to the tap. Introduction The biomechanical advantages to a load sharing anterior lumbar construct have not been debated. NuVasive Expands Complex Spine Portfolio with Global Launch of Reline 3D for Pediatric Deformity. NuVasive ® Yes Aileron ® ... • Impact on future surgical options in the same or adjacent spinal levels. NuVasive Reline system. Tissue Dilation 9 5. A MAS TLIF achieves this by using a less invasive approach to fuse one or more vertebrae together to reduce their motion. • Re-insert the K-wire. We performed extreme lateral interbody fusion (XLIF®, NuVasive, San Diego, CA, USA) combined with PPS (Reline MAS system®, NuVasive) in the lateral position for 15 patients with lumbar diseases since June 2018 and developed our novel strategy and have been using it since September 2018. Materials and Methods: FELIF was … Six consecutive patients (four men and two women) who underwent fusion surgery by this … Titanium rods are placed through the screw heads using the same incision used to place the superior or inferior pedicle screw. This Form SD of NuVasive, Inc. (the “Company”) has been prepared and filed pursuant to Rule 13p-1 promulgated under the Securities Exchange Act of 1934, as amended (the “Rule”), for the reporting period January 1, 2020 to December 31, 2020 (the “Reporting Period”). During the company’s first-quarter earnings call in May, NuVasive CEO Greg Lucier stated that NuVasive plans to launch more than a dozen new products this year spanning from implant systems to the introduction of its Surgical Intelligence platform, in addition to next-generation rods for early-onset scoliosis. Enhance your surgical experience with a reliable system designed for versatile applications. • Minimize common surgical challenges including lateral rod capture, unwanted tower disengagement and rod flattening with thoughtful instrument design. Through this key achievement, SI aims to drive optimized clinical and financial outcomes and improvement of the current state of spine surgery where disparate technologies, data and systems are used today. Sequential reducers … Proxy Statement Pursuant to Section 14(a) of . Building off the success of XLIF, we have continued to develop innovative, less-invasive techniques and technologies for spine surgery, and The Reline 3D system is optimized for the treatment of adolescent idiopathic scoliosis (AIS), which involves intricate surgical techniques to address the … Reline 3D at a Glance. NUVASIVE¤ Ñ DEVELOPING CREATIVE SOLUTIONS FOR SAFE REPRODUCIBLE SPINE SURGERY We are a medical device company focused on the design, development, and marketing of products for the surgical treatment of spine disorders. techniques. We performed a minimally invasive full-endoscopic LIF (FELIF) using a uniportal full-endoscopic system. Reline 3D is a posterior fixation system that unifies traditional deformity techniques into one efficient and holistic procedure. He also receives royalties for IP; Globus Lateral and TLIF Interbody Implants; Medtronic Atlantis, Venture Anterior Plates; Medtronic Prestige ST and LP; NuVasive ALIF; Post Pedicle Screw Reline; and multiple textbooks. Solutions. Pedicle Preparation … – Surgical separation of conjoined twins Secondary Thoracic Insufficiency due to lumbar kyphosis (non gibbus) Contraindications The VEPTR device should not be used under the following conditions: – Inadequate strength of bone (ribs/spine) for attachment of the VEPTR – Absence of proximal and distal ribs for attachment of the VEPTR – Absent diaphragmatic function – Inadequate soft tissue for … QUICk-CONNECt SCREwDRIvER applICatION Step 1 Place the T20 Driver tip into the T20 feature in the screw shank. pedicle screws, hooks and/or connectors). Tip: To properly manage the K-wire, remove the modular T-handle before the tap is fully removed. In a MAS TLIF procedure, rather than starting from the middle of the … However, the decreased blood loss, the lower chance of surgical site infection, and minimized operative time obtained with percutaneous intervention may be of particular benefit in a trauma patient [3]. the Securities Exchange Act of 1934 . NuVasive had actual knowledge of the `200 patent and NuVasive’s 6 unauthorized use thereof as Dr. Jackson offered a license to NuVasive under the 7 application that directly gave rise to the `200 patent on or about March 7, 2019. The company description says this system provides “procedural versatility in a compact midline construct”. Step 5 To disengage, retract the Screwdriver sleeve and unthread the driver from the head of the screw. Finger dissect between the multifidus and longissimus. Modern medicine has offered some revolutionary products and techniques, and many companies are looking to help sustain the pace of medical advances. pedicle screws, hooks and/or connectors). MD-Max™ ULIF System Overview 2 Indications 2 System Features 3 Surgical Technique 6 1. NuVasive Announces Regulatory Approval of Reline? NuVasive Elects Robert F. Friel and Donald J. Rosenberg to Board of Directors 10.2.6.19. Washington, D.C. 20549 . 12 Synthes Surgical technique The following surgical technique is described using the example of a C3–C5 screw insertion. The Reline 3D system is used for the treatment of adolescent idiopathic scoliosis (AIS). Polyaxial pedicle screw length ranges from 30mm to 60mm (up to 2-1/2 inches). The T9 and T10 pedicles were then tapped using a 4.5 mm tap, and 5.5 mm by 40 mm reline NuVasive percutaneous pedicle screws were placed in a standard fashion. implanted using appropriate NuVasive® Reline®, Reline 4.5-5.0 (Reline Small Stature) or Armada® fixation components (i.e. The Telluride 2 system is designed for minimally invasive techniques where small incisions are utilized. This Surgical Technique offers guidance but, as with any such technique guide each surgeon must consider the particular needs of each patient and make appropriate clinical decisions as required. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. A surgical technique guide needs to be as precise as the surgery itself. SURGICAL TECHNIQUE SCREW BED PREPARATION CANNULATION Equipment 2997-04-100 Pedicle Awl 2997-04-105 Straight Thoracic Pedicle Probe 2997-04-110 Curved Thoracic Pedicle Probe 2997-04-115 Straight Lumbar Pedicle Probe 2997-04-120 Curved Lumbar Pedicle Probe 2997-04-125/130 Ball Tip Feeler, Straight/Curved Identify screw entry point and penetrate the cortex using a … Surgical Technique FEATURING EXTENDED TAB PEDICLE SCREW MD-MAX ™ MINIMALLY DISRUPTIVE-MAXIMUM ACCESS SYSTEM ULIF 4139 MD Ma Tc a R_La 1 7/16/15 3:37 PM Pa 2. NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, has launched an immersive VR experience designed to familiarize surgeons with the techniques of their RELINE … For patients with thoracic or lumbar burst fractures, there is no difference in patient outcomes between minimally invasive percutaneous instrumentation and open instrumentation [2]. SURGICAL TECHNIQUE Preparing the Patient Place the patient in a direct lateral decubitus position on the operating room table to ensure suitable visualization of the trajectory of the retraction through the soft tissue. The Maximum Access Surgery transforaminal lumbar interbody fusion (MAS TLIF) procedure is a technique that attempts to eliminate instability in your back through a less invasive approach to fuse one or more vertebrae together to reduce their motion. Although lumbar interbody fusion (LIF) is commonly used for treating LDD, several different treatment strategies are available. Let us take extreme lateral interbody fusion for example. The benefit to the patient is stabilization, possible reduction in pain, VIPER® Cortical Fix Fenestrated Screw System Surgical Technique DePuy Synthes 11 MIS Procedure Cement Delivery Step 2 Insertion of MIS alignment device Check that the alignment device is clear of any cement prior to use. Adverse patient reactions affecting the cardiovascular system, including Bone Cement Implantation Syndrome (BCIS), have been associated with the use of bone cements. Surgical Technique 1 Approach Using the standard surgical approach, expose the spinous processes and laminae of the vertebrae to be fused. SURGICAL TECHNIQUE Fluoroscopic Planning • Use A/P and lateral fl uoroscopy to identify and target the appropriate level(s) • Ensure that the C-Arm is positioned correctly for each targeted level by adjusting the position of the C-Arm until both endplates are parallel and the spinous process is equidistant from the center of each pedicle Lat- eral lumbar interbody … The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical … It involves intricate surgical techniques to tackle three-dimensional deformity present in the spine. it provides surgical access instruments, including Maxcess integrated split-blade retractor system that enable less-invasive surgical techniques by minimizing soft tissue disruption during spine surgery; neuromonitoring systems, which use proprietary software … 6036. ALIF TI INTERFIXATED - CAGE. NuVasive Reline® System (K143684) is a reference device. There is no specific procedure that is unique to the use of the Nuvasive Precept spinal system. Download PDF 20190254769 ... NuVasive, Inc. (San Diego, CA, US) Claims: We claim: 1. efficiency when utilized with the Company’s leading lateral procedural solutions portfolio. NuVasive is a world leader in minimally invasive, procedurally integrated spine solutions. Background: Direct lateral (transpsoas) lumbar interbody fusion (LLIF) reportedly achieves union by 1 year postoperatively, but how soon fusion occurs after these minimally invasive procedures is unclear. those steps has not created holistic surgical approach and can result in an inefficient OR experience. 8 Further, NuVasive, upon information and belief, has the specific intent to 9 encourage surgeons to directly infringe at least claims 1 and 18 of the `200 patent 10 by using and/or … Reline® The Reline portfolio is an innovative posterior fixation technology designed to preserve and restore spinal alignment. NuVasive ® Procedural ... With evolving surgical techniques comes increased demand on the surgical implants. Appropriate realignment is confirmed by fluoroscopy. NuVasive, Inc., a medical technology company, develops, manufactures, and sells procedural solutions for spine surgery. Lumbar interbody fusion is a surgical technique that attempts to eliminate instability in the back. Lumbar interbody fusion is a surgical technique that attempts to eliminate instability in the back. 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. Spinous process fixation devices are not approved by the U.S. Food and Drug Administration (FDA) for stand-alone use; therefore, this indication is considered off-label. The implanted MAGEC Rod is used to brace the spine during growth to minimize the progression of scoliosis. Surgical Plan: Gill laminectomy, MAS PLIF at L5-S1 using Reline MAS Midline and MAS PLIF Ti SURGEON SPOTLIGHT Nitin Khanna, M.D., F.A.A.O.S. The diameter ranges from 5.0mm to 8.5mm (up to 1/4 inch). Systematic Reviews . NuVasive Announces Agreement to Acquire Brazilian Distributor Mega Surgical 10.2.6.18. Lateral MAS Fixation is an adapted technique using Reline®, the Company’s best-in-class fixation system designed to preserve and restore spinal alignment. The use of the system is FDA approved. About NuVasive. All non-sterile devices must be cleaned and sterilized before use. Confirm that the alignment device is fully seated by checking that it is flush with the … Next generation Reline system launches. Step 2 NuVasive MAS ® PLIF Surgical Technique. The purpose of this premarket notification is to revise the labeling to include the NuVasive 5.5 mm Reline and Armada Pedicle Screw Systems. SUrGICaL TECHNIUE GUIDE Step 4 To adjust the screw height, rotate the outer sleeve counter-clockwise. Revenue from our surgical support product line offerings increased $36.3 million, or 14%, in 2016 compared to 2015. SAN DIEGO, June 18, 2020 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally … pedicle screws, hooks and/or connectors). A surgical technique guide needs to be as precise as the surgery itself. Applications and Techniques Brian Hood and Steven Vanni University of Miami, Mill er School of Medicine, Jackson Memorial Hospital, Miami, FL USA 1. F This was repeated at the T5 and T6 levels, albeit with 4.5 mm by 40 mm screws. CoRoent Small, part of the CoRoent family, has been designed specifically for anterior cervical surgery procedures, and is available in a variety of shapes and sizes.
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