Before sharing sensitive information, make sure you're on a federal government site. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Prices excluding VAT and shipping. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. This service located at Oisto.com is a website owned and operated by Oisto. 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 its C360 portfolio. NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. Information you read on this website cannot replace the relationship that you have with your healthcare professional. At NuVasive, we transform surgery, advanced care, and change lives. $749.00. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. About NuVasive PDF NuVasive, Incorporated Ms. Daniela Mahan, Esq., RAC 7475 Lusk Blvd We are excited about the opportunities this acquisition creates as we work to optimize the surgeon experience, advance the standard of care, and create value for shareholders.. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. Reimagine cervical spine surgery. All quotes delayed a minimum of 15 minutes. 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. You should always talk to your healthcare professional for diagnosis and treatment. NuVasive provides patient support and surgeon education. NuVasive provides patient support and surgeon education. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. An official website of the United States government, : 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 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. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. 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. Excluding VAT and shipping. Biologics - NuVasive Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. You should always talk to your healthcare professional for diagnosis and treatment. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. 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. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. 3. ALIF - NuVasive Learn more about the value of Biologics Information you need When fusion is recommended 888 0 obj <>stream 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 . 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. Make sure cookies are enabled in your browser. Forward-Looking Statements In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. It will also discuss the Simplify Medical transaction at that time. Elizabeth Hofheinz, M.P.H., M.Ed. 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. PDF eXtreme - SMISS NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. 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 change patient lives. Price: $5.00 per kit. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. 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. (This story corrected name of Globus Medical in the headline from Global Medical). We do not practice medicine or provide medical services or advice as a part of this website. NV Dynamic Stimulation Clip and Inline Activator. 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. At NuVasive, we aspire to change a patients life every minute. 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. Expected delivery: 2 weeks. D. Device Description Malone, H., Mundis, G. M., Jr., Collier, M, et al. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. NuVasive funded the upfront payment at closing using available cash on hand. NuVasive is the fastest growing, full-line spine company. Adhering to the three core principles of Advanced Materials ScienceSurface, Structure, and ImagingNuVasive has pioneered design and manufacturing methods that combine the inherent benefits of porosity with the advantageous material properties of PEEK and titanium to create implants intelligently designed for fusion. Our Standards: The Thomson Reuters Trust Principles. 1.0 Purpose. NuVasive offers solutions to alleviate patient symptoms. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. 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. Do not implant in patients under 18 years of age. NuVasive is developing the operating room of the future. Product Code: NKB, KWP, MNI, MNH, KWQ C. Predicate Devices The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the PreceptTM (K1025 14), Armada (K092287), and SplzeRx PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. We do not practice medicine or provide medical services or advice as a part of this website. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Fusion is a surgical procedure in which one or more of the vertebrae of the spine are joined together (fused) so that motion no longer occurs between them. (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 . 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. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! Disc space preparation 5. $1,299.99. The San Diego, CA-based company said the RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce . %%EOF 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. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. Potential Biocompatibility Concerns with NuVasive Specialized Excluding VAT and shipping. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. D. Device Description. var base_url = "https://www.medicaldevices24.com/"; NuVasive introduces new Reline 3D posterior fixation system function gtag(){dataLayer.push(arguments);} Three New Biologic Products for Spine Surgery. List of devices made by the manufacturer NUVASIVE, INC. 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.