With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. Pursuant to the terms of the transaction agreement, NuVasive made an upfront payment to Simplify Medical of $150.0 million at closing, subject to customary purchase price adjustments, and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Cervical Artificial Disc technology. All rights reserved. As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices. NuVasive is headquartered in San Diego, California, the US. Eastlack and Mundis as they discuss, Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion?, recently published in the Journal of Neurosurgery Spine. Elizabeth Hofheinz, M.P.H., M.Ed. Home | NuVasive Reimagine cervical spine surgery. If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). Open the catalog to page 2 What is causing my pain? That no more than two devices should be implanted at a time. Peer-to-peer discussion between Drs. One comprehensive system. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. All products | NuVasive Webshop The Sage Lateral Plate System The SRS-Schwab adult spinal deformity classification: Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices. At NuVasive, we transform surgery, advanced care, and change lives. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. You don't have to face this journey alone. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. Becoming the number one partner in pediatrics. Expected delivery: 3 weeks. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. This service located at Oisto.com is a website owned and operated by Oisto. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. Duan R, Barbieri D, Luo X, et al. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. Address 7475 Lusk Blvd, San Diego, California, 92121. NuVasive provides patient support and surgeon education. The Instructions for Use for titanium-based Precice devices have been updated to include: For Titanium-Based Precice devices (Precice IMLL, Precice Short, Precice Freedom, Precice Unyte): Note: Stainless steel-based Precice devices remain recalled from the U.S. market. NuVasive is developing the operating room of the future. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. The contents of this Site, including but not limited to the text and images herein and their arrangements, unless otherwise noted, are the copyrighted material of Oisto. At NuVasive, we transform surgery, advanced care, and change lives. The discussions between the companies are preliminary and there is no certainty that a deal will be reached, the sources added, requesting anonymity because the matter is confidential. NuVasive Acquires Simplify Medical - NuVasive D. Device Description PDF San Diego, CA 92121 PCM - Food and Drug Administration NuVasive Inc Company Profile - GlobalData In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. UPDATE: Potential Concerns with NuVasive Precice Devices PDF NVM5 Computer-Assisted Rod Bending Spine 2020;45(14):944-51. $749.00. Do not implant more than two devices in a patient at once. from FortisBC Holdings Inc for C$400 million ($294.68 million). NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The materials on this website are for your general educational information only. Sign in to add this product to your favorites! As demonstrated by the strong clinical data and the unique design characteristics of the Simplify Disc, we share NuVasives focus on outcome-driven innovation, said David Hovda, president and chief executive officer of Simplify Medical. San Diego, California 92121 Re: K210214 Trade/Device Name: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. ET / 1:30 p.m. PT to discuss these results. The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from stainless steel and titanium. This is why we show up every day, united and committed to our vision. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Malone, H., Mundis, G. M., Jr., Collier, M, et al. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. See here for a complete list of exchanges and delays. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. As of date of publication, March 2017; data on file. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. We do not practice medicine or provide medical services or advice as a part of this website. WestCMR does not provide advice, training, or clinical support. D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (TI-SI). You should always talk to your healthcare professional for diagnosis and treatment. NuVasive is committed to a global approach for assessing, preserving, and restoring spinal alignment in an effort to promote surgical efficiencies, lasting patient outcomes, and improved quality of life. Propel DBM Fibers and Propel DBM Sponge are 100% bone and are intended for homologous use in the repair, replacement, or reconstruction of skeletal defects. The integration of XLIF, XALIF, and XFixation into a single platform enables surgeons to treat a patient without repositioning, which may reduce patient time under anesthesia and hospital costs. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Please close the page and access the Company Store via Okta. Get your money back!. Clinical benefits ALIF Anterior approaches, such as in ALIF, allow access to the discs at the front of the spine and do not require muscle stripping as in posterior approaches. multi-level pathologies. Price: $5.00 per kit. The subject NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. NuVasive introduces new Reline 3D posterior fixation system Excluding VAT and shipping. NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. 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. 4. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. %%EOF Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. 8050015: NuVasive NVM5 EMG Needle Module. All Trademarks & Logos belong to their respective owners. NuVasive offers solutions to alleviate patient symptoms. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl Surgical efficiency meets reliable versatility. Rethink how you buy and sell surgical supplies. Expected delivery: 3 weeks. Three New Biologic Products for Spine Surgery. Excluding VAT and shipping. Headquarters United States of America. In an effort to evolve the standard of care for early-onset scoliosis (EOS) and adolescent deformity patients, we have invested in a comprehensive product portfolio that introduces surgical efficiencies and optimized implant constructs, and we remain committed to supporting the progression of clinical education and scientific research in this space. Simplify Medicals technology was designed to offer surgeons best-in-class capabilities for cTDR across key performance functions, including: NuVasive will leverage its commercial and distribution channels in the U.S. and international markets to drive utilization of the Simplify Disc. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. Read the press release About NuVasive The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. NuVasive is now able to address all key segments of the cervical spine by offering comprehensive, procedurally integrated solutions across anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), and cTDR procedures. Alignment Matters . Excluding VAT and shipping. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. All Trademarks referred to are the property of their respective owners. San Diego, CA 92121 PCM THE CERVICAL DISC SYSTEM INSTRUCTIONS FOR USE Rx Only GRAPHICAL SYMBOLS Read Instructions Before Use Single Use Only Catalog Number Lot Number STLE RSterile by Irradiation Non-Sterile, Sterilize by Steam before Use Manufacturer Use By HOW SUPPLIED We believe in the importance of preoperative decision-making and support toolsinformed by data and clinical experiencepaired with novel, intraoperative tools to execute a surgeon-specific plan. Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. NV Dynamic Stimulation Clip and Inline Activator. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. The Simplify Disc is supported by level-1 evidence through the FDA investigational device exemption (IDE) study1 and was found to be clinically superior to ACDF in the randomized controlled trial. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. COCCYX ZONE OF SPINE FOR. Following the commercial launch of the NuVasive ACP system and the Simplify Cervical Disc, we have recently introduced a posterior cervical fusion solution, Reline Cervical. NuVasive provides patient support and surgeon education. Innovation in Musculoskeletal Solutions | Globus Medical The acquisition of Simplify Medical advances our previously communicated long-term growth strategy by both expanding, and further distinguishing, our portfolio with industry-leading innovation, said J. Christopher Barry, chief executive officer of NuVasive. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. PCF - NuVasive - PDF Catalogs | Technical Documentation The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Product Code: LLZ C. Predicate Devices The subject NuVasive NuvaLine is substantially equivalent to the primary predicate NuVasive NuvaLine Mobile App (K162647) and additional reference devices NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus Image Mangement System (K171130). You have not been assigned a username and password. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. Disc space preparation 5. Bone grafting is a surgical technique that involves implanting a bone substitute or extender to help the body achieve spinal fusion. 'VUJ)(h. Alignment. PLoS ONE 2011;6(10):1-8. Do not implant in patients under 18 years of age. gtag('config', 'G-XBG07ECKJ5'); BOLTS FOR SMALL CAGE COROENT INTERLOCK NUVASIVE, CERVICAL DISC PROSTHESIS CERPASS NUVASIVE, CONNECTOR AND NUT CLOSURE STERILE - VUEPOINT II, COROENT CAGE SMALL SCREW INTERLOCK NUVASIVE, COROENT LARGE OBLIQUE STERILE - CAGE INTERSOMATICO, COROENT SMALL INTERLOCK II - CAGE INTERBODY, COROENT XL TITANIUM BARREN - CAGE INTERBODY, DYNAMIC STIMULATION AND INLINE CLIP APPLICATOR, HOOK AND NUT CLOSURE STERILE - VUEPOINT II, LIVES FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, NV M5 XLIF KIT WIRE KIRSCHNER AND DILATOR, SCREWS E NUT CLOSURE STERILE - VUEPOINT II, STAPLE FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, SYSTEM COROENT XL STERILE - CAGE INTERBODY, THE PAS-II PEDICLE INSULATED SYSTEM ACCESS, Complete classification of medical devices. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. Expected delivery: 2 weeks. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. %PDF-1.4 % NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. Quantity: Osteocel provides a complete and physiologic bone graft that contains all of the necessary components for bone growth: the cells, the signals, and the scaffold. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. Intelligently designed for fusion. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. Information you read on this website cannot replace the relationship that you have with your healthcare professional. PDF User Manual - Nuwave Cpap Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. Plenty of storage and clever organisation for life on the go, Store a 15.6" laptop in the dedicated compartment padded with EVA Impact Foam for extra protection, Spacious main compartment with structured slip pockets for a tablet, For organising a portable charger, cables and accessories, Lightweight collapsible pitchfork made of high-quality ABS plastic, Equipped with a magnetic ball marker with Nuvasive logo-doming, Kobaldeck playing cards are of absolute top quality, Back of cards and box are printed with Nuvasive logo, Receptacles for Europe, USA/Japan, Australia/China, All international security-relevant standards and norms, Keeps your drinks cold for 8 hours and hot for 5, Height 25cm, diameter 7cm - Volume: 500 ml, Ergonomic design provides a comfortable fit for your ears, Handy pocket-size power booster - 5000mah. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to help transform spine surgery, and ultimately change the lives of your patients. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Three New Biologic Products for Spine Surgery The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Previously, on April 5, 2021, NuVasive had posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. Voluntary reports can be submitted through, Device manufacturers and user facilities must comply with the applicable, Health care personnel employed by facilities that are subject to the. 1.0 Purpose. COMPANY CONFIDENTIAL. Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. Forward-Looking Statements NuVasive has struggled with the impact that healthcare staffing shortages and weaker demand for elective surgery have had on its sales since the onset of the COVID-19 pandemic. Unhappy? Product images are for display only. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. Height 25cm, diameter 7cm - Volume: 500 ml. PDF NuVasive, Incorporated Ms. Daniela Mahan, Esq., RAC 7475 Lusk Blvd PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible This power bank is suitable for charging any device. Login - NuVasive Company Store - Direct EDJE Based on review of publicly available materials at the time of this release. Expected delivery: 3 weeks. NuVasive Launches Next-Gen Reline Spine Fixation System It will also discuss the Simplify Medical transaction at that time. The FDA continues to work with NuVasive to: The FDA will continue to keep health care providers and the public informed as new or additional information becomes available. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. You should always talk to your healthcare professional for diagnosis and treatment. Make sure cookies are enabled in your browser. All quotes delayed a minimum of 15 minutes. Biomater Sci 2018;6:136-45. 5. The Companys comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. D. Device Description. For more information, please visit www.nuvasive.com. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. NuVasive Company Profile - Office Locations, Competitors, Revenue Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. window.dataLayer = window.dataLayer || []; 809 0 obj <>/Filter/FlateDecode/ID[]/Index[789 100]/Info 788 0 R/Length 99/Prev 1608803/Root 790 0 R/Size 889/Type/XRef/W[1 2 1]>>stream Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. $5,499.99. or more while undergoing treatment, and. Expected delivery: 3 weeks. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. NUVASIVE: 2012022 - WestCMR Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. 2Data on file. Transaction Details NUVASIVE: 2012022 SKU# 2012022-WE1. PDF NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs System At NuVasive, we transform surgery, advanced care, and change lives. The unique microarchitecture of Attrax drives the differentiation of mesenchymal stem cells (MSCs) into bone-forming osteoblasts without added growth factors.2 The optimized microarchitecture of Attrax is engineered using tightly controlled parameters for a defined micropore size distribution within 0.3 to 1.1 microns, demonstrated to initiate greater bone formation compared to traditional ceramics.3, Attrax Putty is one of only a few bone grafting devices on the market supported by a Level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.4. Excluding VAT and shipping. Simplify Medical is located in Sunnyvale, California. nuvasive product catalog pdf hb```b````e`ad@ A(GcG!O HW7o.[S.8{bZx{f(*m(!$ d9>k=ggx rM},(qS>gz}":IHH]1s1@lL j,l l@6kzGkFGkfTt4E# `(AokavH8XVh|Pi\P(d. 50 - 99 pieces - 8,75. Nov 15 (Reuters) - Globus Medical Inc (GMED.N) has approached NuVasive Inc (NUVA.O), a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar with the matter said. CODE: NS10000565. The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. SAN DIEGO February 24, 2021 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it has acquired Simplify Medical, a privately held company and developer of the Simplify Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR). Biologics - NuVasive 2.0 Scope NuVasive Launches Modulus ALIF 3D-Printed Porous Titanium Implant for devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. Neurocare Products. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. NuVasive is developing the operating room of the future. Thu, October 4th, 2018. NuVasive logo printed in 1 colour Prices (minimum order quantity 10 pieces) 10 - 24 pieces - 22,65 25 - 49 pieces - 19,30 50 - 100 pieces - 17,60 more than 100 pieces - please contact us for a new quote. Our Standards: The Thomson Reuters Trust Principles. For care of patients who currently have one of these devices and weigh less than 50 pounds and/or have more than two devices implanted, the health care team should assess treatment progression and consider removal of nails promptly at the end of treatment. Prices(minimum order quantity 10 pieces)10 - 24 pieces - 22,6525 - 49 pieces - 19,3050 - 100 pieces - 17,60more than 100 pieces - please contact us for a new quote.Expected delivery: 3 weeks. NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasives results to differ materially from historical results or those expressed or implied by such forward-looking statements. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f Evaluate additional biocompatibility assessments intended to address specific biocompatibility concerns with all Precice devices and collect additional data to better understand the risks to patients. Prices excluding VAT and shipping. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. NuVasive offers solutions to alleviate patient symptoms. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. For the best experience on our site, be sure to turn on Javascript in your browser. To learn more, visit www.simplifymedical.com. Appropriate patient positioning 2. Robert Eastlack and Gregory Mundis. All rights reserved. Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined companys products and technologies; and the risk that benefits from the acquisition may not be fully realized or may take longer to realize than expected.
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