Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. Forward-Looking Statements 1997-2023 WestCMR. 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. Investor Conference Call Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. NuVasive Inc Company Profile - GlobalData Disc space preparation 5. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. window.dataLayer = window.dataLayer || []; The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. Duan R, Barbieri D, Luo X, et al. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! Robert Eastlack and Gregory Mundis. NUVASIVE: 2012022 - WestCMR The SRS-Schwab adult spinal deformity classification: Letters to Health Care Providers, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, MedWatch, the FDA Safety Information and Adverse Event Reporting program, July 2021 letter to health care providers, Medical Device Reporting (MDR) regulations, FDA's user facility reporting requirements, Division of Industry and Consumer Education (DICE), Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, Precice Intra-medullary Limb Lengthening Device. In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. function gtag(){dataLayer.push(arguments);} NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. NuVasive offers solutions to alleviate patient symptoms. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. Expected delivery: 2 weeks. Surgical efficiency meets reliable versatility. 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). %PDF-1.4 % NuVasive funded the upfront payment at closing using available cash on hand. 2020 - 5. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. 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. Implant insertion See here for a complete list of exchanges and delays. An integrated technology platform to enable better spine surgery. Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. Excluding VAT and shipping. The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. We do not practice medicine or provide medical services or advice as a part of this website. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Tell us something about it and help others to make the right decision, We use UPS, Fedex, USPS and our sellers ship quickly and securely, Customer satisfaction is our top priority, we are not happy until you are happy. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. Simplify Cervical Artificial Disc provides NuVasive most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment, Expands growth opportunities and further differentiates Companys comprehensive portfolio across ACDF, PCF, and cTDR procedures. 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. NUVASIVE: 2012022 SKU# 2012022-WE1. NuVasive Launches Next-Gen Reline Spine Fixation System $650.00. The potential combination would accelerate consolidation in the spine surgery market, where smaller players are turning to dealmaking to compete against the likes of Johnson & Johnson (JNJ.N), Medtronic Plc (MDT.N) and Zimmer Biomet Holdings Inc (ZBH.N). Biomater Sci 2018;6:136-45. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! Bone grafting is a surgical technique that involves implanting a bone substitute or extender to help the body achieve spinal fusion. Propel DBM Putty Plus and Gel Plus contain added cancellous chips and serve as a bone graft extender (extremities, posterolateral spine, pelvis) and bone void filler of the extremities and pelvis. Make sure cookies are enabled in your browser. Prices excluding VAT and shipping. Simplify Medical is located in Sunnyvale, California. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. Headquarters United States of America. Prices excluding VAT and shipping. Propel DBM is donated human bone that has been demineralized to remove the minerals and cells contained in the bone while retaining the collagen matrix and growth factors, including bone morphogenetic proteins, inherent to the tissue. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. 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. At NuVasive, we transform surgery, advanced care, and change lives. 50 - 99 pieces - 8,75. The NuVasive TLIF philosophy, coupled with its comprehensive portfolio, provides open and MAS procedural systems that include the requisite tools surgeons need to plan surgery, access affected levels, restore alignment and disc height, provide optimized fixation, and deliver graft material. The subject Copyright 2022 Oisto. 4. If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121 Re: K191974 Trade/Device Name: NuVasive AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Photos are for illustration purposes only and may not depict the exact item. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. DLA Piper is serving as NuVasives legal counsel. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. PDF NuVasive, Incorporated March 25, 2020 - Food and Drug Administration Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. About NuVasive Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. 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. 1.0 Purpose. 1 Terran J, Schwab F, Shaffrey CI, et al. NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. Information you read on this website cannot replace the relationship that you have with your healthcare professional. See here for a complete list of exchanges and delays. 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. 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. multi-level pathologies. It will also discuss the Simplify Medical transaction at that time. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. ET / 1:30 p.m. PT to discuss these results. Journal of Neurosurgery Spine. iMedSales is a premier surgical and medical equipment supplier that provides a combina Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~, Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image, STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG, Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill, Karl Storz 22220154 HD Image 1 H3M Microscope, Dr 3-Chip Camera, Karl Storz 20132020 Xenon Light Source 175 Watt ~ Lamp only has 13 hours, Medical Blue Nitrile Gloves Latex Free, Powder Free, Textured, Disposable, Non-Sterile 100 pieces per box of 1. You should always talk to your healthcare professional for diagnosis and treatment. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f 888 0 obj <>stream 2Data on file. Appropriate patient positioning 2. By using modern education principles, competency-based curriculum, and multi-modal learning pathways, the CPD team and its dedicated surgeon faculty provide an unparalleled learning experience for surgeons and their staff around the globe. The Sage Lateral Plate System Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 13,8750 - 99 pieces - 8,75100 - 200 pieces - 7,86more than 200 pieces - please contact us for a new quote. To learn more, visit www.simplifymedical.com. 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 disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. One comprehensive system. Before sharing sensitive information, make sure you're on a federal government site. NuVasive is developing the operating room of the future. Osteocel is human tissue donated specifically for human clinical use. December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics' Precice devices made from. Transaction Details (Top row): NuVasive DBM putty and gel and NuVasive amniotic membrane DS (Bottom Row): Traditional bone allograft and DBM fibers / Courtesy of NuVasive, Inc. NuVasive, Inc. has announced U.S. commercial launch of three new biologics . The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. Address 7475 Lusk Blvd, San Diego, California, 92121. Globus Medical Inc has approached NuVasive Inc , a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar . Excluding VAT and shipping. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto ALIF - NuVasive 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. 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. All Trademarks & Logos belong to their respective owners. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. List of devices made by the manufacturer NUVASIVE, INC. 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. from FortisBC Holdings Inc for C$400 million ($294.68 million). Information you read on this website cannot replace the relationship that you have with your healthcare professional. 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. Neurocare Products. Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; Excluding VAT and shipping. 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. The three essential biologic mechanisms involved in complete bone grafts include osteoconduction (a scaffold for the reparative growth of the natural bone), osteoinduction (signals encouraging undifferentiated cells to become active osteoblasts), and osteogenesis (living bone cells in the graft material contribute to bone remodeling). At NuVasive, we transform surgery, advanced care, and change lives. Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. 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. Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE The X360 System is a comprehensive approach to lateral single-position surgery powered by Surgical Intelligence, an ecosystem of technologies enabling safer, faster, smarter surgery. 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. Combining the Simplify Disc with NuVasives C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. All Trademarks referred to are the property of their respective owners. xZrJ]e7,[Uv%d|7@$$! D. Device Description Retroperitoneal access 3. ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. Price: $5.00 per kit. We do not practice medicine or provide medical services or advice as a part of this website. %%EOF Malone, H., Mundis, G. M., Jr., Collier, M, et al. Innovation in Musculoskeletal Solutions | Globus Medical It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. PDF NVM5 Computer-Assisted Rod Bending Globus, which is a provider of implantable devices and instruments used in spinal and orthopedic surgeries, made an indicative cash-and-stock offer for NuVasive in recent weeks, the sources said. PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory endstream endobj startxref Leading Independent Proxy Advisory Firm Glass Lewis Joins ISS in Recommending NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, Leading Independent Proxy Advisory Firm ISS Recommends NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, NuVasive to Participate in Upcoming Global Spine Conferences, NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients. Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. 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. NuVasive is the fastest growing, full-line spine company. Alignment. 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. Three New Biologic Products for Spine Surgery As of date of publication, March 2017; data on file. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. var base_url = "https://www.medicaldevices24.com/"; The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. NuVasive introduces new Reline 3D posterior fixation system Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Product images are for display only. 789 0 obj <> endobj Login - NuVasive Company Store - Direct EDJE $1,299.99. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to . 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. Website www.nuvasive.com. The materials on this website are for your general educational information only. Neurostimulators & Components. Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. Quantity: The industry leader for online information for tax, accounting and finance professionals. $749.00. Expected delivery: 3 weeks. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote.
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