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. 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. Please close the page and access the Company Store via Okta. At NuVasive, we transform surgery, advanced care, and change lives. All products sold by WestCMR are in-date. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. 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. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. For the best experience on our site, be sure to turn on Javascript in your browser. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. See here for a complete list of exchanges and delays. 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. Price: $5.00 per kit. 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. Expected delivery: 3 weeks. 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.. 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. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. Excluding VAT and shipping. NuVasive is headquartered in San Diego, California, the US. Canadian pipeline operator Enbridge Inc said on Monday it would acquire Aitken Creek natural gas storage facility in British Columbia (B.C.) Prices excluding VAT and shipping. 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. 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. You should always talk to your healthcare professional for diagnosis and treatment. 1 Terran J, Schwab F, Shaffrey CI, et al. Three New Biologic Products for Spine Surgery. Excluding VAT and shipping. NuVasive is developing the operating room of the future. Retroperitoneal access 3. As of date of publication, March 2017; data on file. In this video, they review the findings around improved patient outcomes and reduced economic burden when using these products together. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. COMPANY CONFIDENTIAL. The Sage Lateral Plate System NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. or more while undergoing treatment, and. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. 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, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. It will also discuss the Simplify Medical transaction at that time. Do not implant in patients under 18 years of age. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Information you read on this website cannot replace the relationship that you have with your healthcare professional. All Trademarks & Logos belong to their respective owners. Information you read on this website cannot replace the relationship that you have with your healthcare professional. NuVasive provides patient support and surgeon education. Expected delivery: 2 weeks. Peer-to-peer discussion between Drs. 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. One position. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. Simplify Medical is located in Sunnyvale, California. xZrJ]e7,[Uv%d|7@$$! The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. Website www.nuvasive.com. Alignment. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. 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. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. NuVasive Launches Modulus ALIF. 0 This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. All quotes delayed a minimum of 15 minutes. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. 2Data on file. 3. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. D. Device Description The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. 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. For the best experience on our site, be sure to turn on Javascript in your browser. 50 - 99 pieces - 8,75. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. 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. 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. 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). NuVasive is developing the operating room of the future. NuVasive funded the upfront payment at closing using available cash on hand. 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. 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. westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. The subject NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. Becoming the number one partner in pediatrics. All rights reserved. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. 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. var site_url = "https://www.medicaldevices24.com/"; Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. Appropriate patient positioning 2. Information you read on this website cannot replace the relationship that you have with your healthcare professional. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. NuVasive is the fastest growing, full-line spine company. Reimagine cervical spine surgery. 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. Forward-Looking Statements Address 7475 Lusk Blvd, San Diego, California, 92121. 2020 - 'VUJ)(h. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. %%EOF 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 RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! To learn more, visit www.simplifymedical.com. Surgical efficiency. 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 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. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. Intelligently designed for fusion. An integrated technology platform to enable better spine surgery. Before sharing sensitive information, make sure you're on a federal government site. 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. (This story corrected name of Globus Medical in the headline from Global Medical). Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Excluding VAT and shipping. Learn how intelligent surgery can change your practice. 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 . Sign in to add this product to your favorites! The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! If so, do not buy this item unless you are an authorized purchaser. JavaScript seems to be disabled in your browser. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. 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. 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. Expected delivery: 3 weeks. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. 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 . 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream Based on review of publicly available materials at the time of this release. 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. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. 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. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. Spine 2020;45(14):944-51. %PDF-1.4 % In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. $650.00. NuVasive is the fastest growing, full-line spine company. Expected delivery: 3 weeks. 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. The materials on this website are for your general educational information only. The site is secure. 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. The SRS-Schwab adult spinal deformity classification: 1. 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 1997-2023 WestCMR. The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. Advisors It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Duan R, Barbieri D, Luo X, et al. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. Implant insertion Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. Disc space preparation 5. 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. Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. If the item is subject to FDA regulation, seller must verify your status as an authorized purchaser of this item before shipping of the item. You don't have to face this journey alone. Returns are simple. That no more than two devices should be implanted at a time. 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. 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). The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. 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. multi-level pathologies. Lehr MA, Oner CF, Delawi D, et al. We do not practice medicine or provide medical services or advice as a part of this website. NuVasive offers solutions to alleviate patient symptoms. $1,299.99. Alignment Matters . At NuVasive, we aspire to change a patients life every minute. See here for a complete list of exchanges and delays. Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). Surgical efficiency meets reliable versatility. NuVasive offers solutions to alleviate patient symptoms. Biomater Sci 2018;6:136-45. This is why we show up every day, united and committed to our vision. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. Our Standards: The Thomson Reuters Trust Principles. var base_url = "https://www.medicaldevices24.com/"; CODE: NS10000565. 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. Exclusive news, data and analytics for financial market professionals, Reporting by Greg Roumeliotis in New York, US FDA declines to approve Ascendis' hormone disorder therapy, Astellas Pharma buys Iveric Bio for $5.9 billion, Pfizer, BioNTech propose EU pays half for each cancelled COVID dose, Financial Times reports, Indian cough syrup: mystery middleman may be new clue, Enbridge acquires gas storage facility in British Columbia for $295 million, Adani-owned NDTV profit plunges about 98% on weak advertising demand, U.S. FAA opens new direct plane routes ahead of summer travel, Russia temporarily halts gas supply to Armenia for planned maintenance, Norwegian Cruise lifts profit forecast on higher ticket prices, steady demand. 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. NuVasive is the fastest growing, full-line spine company. 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. The website is intended to provide information that might be of interest to users. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. Elizabeth Hofheinz, M.P.H., M.Ed. Copyright 2022 Oisto. from FortisBC Holdings Inc for C$400 million ($294.68 million). At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. Excluding VAT and shipping. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. $5,499.99. One comprehensive system. Transaction Details Learn more about the value of Biologics Information you need When fusion is recommended Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. 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. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230). Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers.
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