(This story corrected name of Globus Medical in the headline from Global Medical). Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. 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. You have not been assigned a username and password. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. or more while undergoing treatment, and. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f 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. Appropriate patient positioning 2. Biomater Sci 2018;6:136-45. 50 - 99 pieces - 8,75. An integrated technology platform to enable better spine surgery. 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. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. $650.00. The SRS-Schwab adult spinal deformity classification: Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. The materials on this website are for your general educational information only. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. 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 . 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. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. Reimagine cervical spine surgery. 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. See here for a complete list of exchanges and delays. 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. See here for a complete list of exchanges and delays. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory NuVasive is the fastest growing, full-line spine company. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. Expected delivery: 3 weeks. window.dataLayer = window.dataLayer || []; The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Duan R, Barbieri D, Luo X, et al. Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. NuVasive is developing the operating room of the future. The .gov means its official.Federal government websites often end in .gov or .mil. NuVasive is developing the operating room of the future. Our Standards: The Thomson Reuters Trust Principles. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. UPDATE: Potential Concerns with NuVasive Precice Devices 2Data on file. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. Information you read on this website cannot replace the relationship that you have with your healthcare professional. You should always talk to your healthcare professional for diagnosis and treatment. The site is secure. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. Malone, H., Mundis, G. M., Jr., Collier, M, et al. PDF NVM5 Computer-Assisted Rod Bending Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. List of devices made by the manufacturer NUVASIVE, INC. %%EOF 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. NuVasive is headquartered in San Diego, California, the US. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. Forward-looking statements include, but are not limited to, statements about the potential benefits of the acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. 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. Spine 2020;45(14):944-51. 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. Elizabeth Hofheinz, M.P.H., M.Ed. gtag('js', new Date()); About NuVasive Expected delivery: 3 weeks. About Simplify Medical Excluding VAT and shipping. Implant insertion Expected delivery: 2 weeks. Sign in to add this product to your favorites! NV Dynamic Stimulation Clip and Inline Activator. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. You should always talk to your healthcare professional for diagnosis and treatment. 789 0 obj <> endobj Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. 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. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto function gtag(){dataLayer.push(arguments);} NuVasive is the fastest growing, full-line spine company. Retroperitoneal access 3. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. Potential Biocompatibility Concerns with NuVasive Specialized Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 PDF Document Title: Visual and Cosmetic Standards for Manufacturing One comprehensive system. Open the catalog to page 2 What is causing my pain? RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. Peer-to-peer discussion between Drs. NuVasive provides patient support and surgeon education. 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. 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. 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. All products | NuVasive Webshop var site_url = "https://www.medicaldevices24.com/"; 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. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. Surgical efficiency meets reliable versatility. 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. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. 1. 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. NUVASIVE: 2012022 - WestCMR