Weve partnered with the worlds leading surgeons to advance cervical surgery and deliver a comprehensive, procedurally integrated portfolio for anterior and posterior cervical proceduresC360. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! Three New Biologic Products for Spine Surgery Expected delivery: 3 weeks. 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. Surgical efficiency meets reliable versatility. 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. We do not practice medicine or provide medical services or advice as a part of this website. %PDF-1.4 % 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 The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). Neurocare Products. Osteocel is a comprehensive bone graft developed to mimic the properties of a patient's own bone. It will also discuss the Simplify Medical transaction at that time. In this video, they review the findings around improved patient outcomes and reduced economic burden when using these products together. 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. Expected delivery: 3 weeks. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f $1,299.99. Investor Conference Call Elizabeth Hofheinz, M.P.H., M.Ed. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. Alignment. window.dataLayer = window.dataLayer || []; from FortisBC Holdings Inc for C$400 million ($294.68 million). N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. Transpsoas access 4. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. Excluding VAT and shipping. 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. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. An integrated technology platform to enable better spine surgery. ET / 1:30 p.m. PT to discuss these results. The SRS-Schwab adult spinal deformity classification: At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. 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. NuVasive Company Profile - Office Locations, Competitors, Revenue Disc space preparation 5. For the best experience on our site, be sure to turn on Javascript in your browser. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. 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. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. (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 . /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 17,7550 - 99 pieces - 15,90100 - 150 pieces - 14,70more than 150 pieces - please contact us for a new quote. NuVasive Launches Modulus ALIF. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream Lehr MA, Oner CF, Delawi D, et al. The site is secure. WestCMR does not provide advice, training, or clinical support. Expected delivery: 3 weeks. Before sharing sensitive information, make sure you're on a federal government site. 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. 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. 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). Excluding VAT and shipping. 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. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. Advisors Expected delivery: 3 weeks. Neurostimulators & Components. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Biomater Sci 2018;6:136-45. Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. 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. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine. Reimagine cervical spine surgery. NuVasive provides patient support and surgeon education. 1. Innovation in Musculoskeletal Solutions | Globus Medical Based on review of publicly available materials at the time of this release. You should always talk to your healthcare professional for diagnosis and treatment. These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. NuVasive introduces new Reline 3D posterior fixation system The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's 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. Intelligently designed for fusion. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. NuVasive offers solutions to alleviate patient symptoms. 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. Learn more about the value of Biologics Information you need When fusion is recommended 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. 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. 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. Whether preserving or restoring spinal alignment, the seamless and versatile design of Reline provides one system to address even the most difficult pathologies. NuVasive Inc Company Profile - GlobalData Information you read on this website cannot replace the relationship that you have with your healthcare professional. Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. 1997-2023 WestCMR. 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 materials on this website are for your general educational information only. 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. At NuVasive, we transform surgery, advanced care, and change lives. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. Peer-to-peer discussion between Drs. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. 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. Rethink how you buy and sell surgical supplies. 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. It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. NuVasive offers solutions to alleviate patient symptoms. Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. 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. All rights reserved. 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). 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. We do not practice medicine or provide medical services or advice as a part of this website. 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. 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. NuVasive is the fastest growing, full-line spine company. 888 0 obj <>stream The Sage Lateral Plate System Three New Biologic Products for Spine Surgery. DLA Piper is serving as NuVasives legal counsel. NuVasive Launches Next-Gen Reline Spine Fixation System 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. The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. 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. Do not implant in patients under 18 years of age. *Data on file. 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 D. Device Description. See here for a complete list of exchanges and delays. 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. You should always talk to your healthcare professional for diagnosis and treatment. Sign in to add this product to your favorites! 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. PDF Document Title: Visual and Cosmetic Standards for Manufacturing 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. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel.