In addition, the TAS features three integrated grit-blasted screws that allow up to ten degrees of medial/lateral or anterior/posterior angulation. This breakthrough inspired a revolution in surface technology, leading directly to a proprietary combination of textures that altered the interbody fusion market. About the Company Titan Spine, LLC is a privately-owned medical implant surface technology company in Mequon, Wisconsin that is focused on the design and manufacturing of proprietary interbody fusion devices for the spine. Find company research, competitor information, contact details & financial data for DAMART of ROUBAIX, HAUTS DE FRANCE. MEQUON, Wis.- (BUSINESS WIRE)-Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has. If they have further distributed the product they should identify their customers and advise Titan Spine of their contact information. Distributed in the states of CA, TX, OK, MA, NY, IN, OR, and GA. I felt theprocedure went very well and the surgical technique was simple and straightforward,commented Dr. Henderson. Cages are designed without ridges and teeth, so interbodies do not damage the vertebral endplate and avoid subsidence. Talk with your doctor and family members or friends about deciding to join a study. Please remove one or more studies before adding more. The Endoskeleton TT is a titanium alloy interbody device designed to aid in the fusion of 1 or 2 contiguous levels between L2 and S1 through a TLIF. Fred Geisler, neurosurgeon at The Chicago Back Institute in Chicago, Illinois, USA, was also one of the first surgeons to implant the device, he said, I was particularly impressed with the purchase of the screws and how the roughened surface of the implant prevented the device from moving during screw insertion., The combination of immediate stabilisation and the osteoinductive properties of the implants micro and nano textures represent a significant advance in spine surgery. August 2016 How these engineers make DeviceTalks Boston go. This event is set to bring together leading manufacturers, suppliers, importers and experts from around the world to showcase the latest innovations, technologies, and products in [], A consortium in the Netherlands received a $20 million (19 million) roadmap grant from NWO (the Dutch Research Counsel). Why are Sales Reps a key piece in the success of the Globus and Nuvasive merger? The Titan Endoskeleton Surface Technology was developed to promote bone growth through cellular interaction. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media. Three integrated, grit-blasted screws provide immediate mechanical stability. s aux critures et techniques varies Ven 10.03.23. Interbody Science We feel that we are well positioned to continue to increase our market share and meet the growing need of spine surgeons looking for innovative interbody implants that create a superior osteogenic environment for their patients.. Hyperlordotic implants are those defined by a lordotic angle 16. Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has received FDA clearance to commercially release its Endoskeleton TAS system, consisting of an ALIF device with integrated fixation screws. I look forward to adding the TAS to my practice., Kevin Gemas, President of Titan Spine, commented, The addition of the Endoskeleton TAS to our product line now allows us to address approximately 90% of the interbody market that is approaching $1 billion in domestic annual sales. The letters described the problem and the product involved in the recall. Lundi au vendredi de 05h10 20h20. Durham, North Carolina-based Isolere Bio develops new and proprietary IsoTag reagents and filtration processes used for the purification and streamlined manufacturing of biopharmaceuticals. I look forward to adding the TAS to my practice., Kevin Gemas, president of Titan Spine, commented, The addition of the Endoskeleton TAS to our product line now allows us to address approximately 90% of the interbody market that is approaching US$1 billion in domestic annual sales. Listing a study does not mean it has been evaluated by the U.S. Federal Government. November 2014 Efficient surgical workflow with a smooth leading edge aid in insertion. 04/13/2017) Additional Predicates . The subject devices . The micro level (10-6m) features osteoclastic-sized pits on all external and interior surfaces. The Endoskeleton TAS incorporates the same macro, micro, and nano surface textures as the companys Endo TA ALIF device, which has been shown to elicit a superior osteogenic response in comparison to other commercially available interbody materials. Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. xr\lY'~00)"f~tu|fm]65of_n7'ys:'/|S=yT'M3&DW:2!~t+x6_-fEa|g9dGezL^(|+)qY5/_',Wd}9&o7&X]#E)jvY&lGlx5]7,2='~6.~] Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. Titan Products. July 2016 Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. Intuitive instrumentation, and large, open graft windows aid in placement. Osseus Announces First Ever FDA Standalone Indication for Integrated ALIF with Alternative Fixation. Get the latest updates about interbody science, training, and events. "I am pleased to initiate use of Titan Spine's Endoskeleton TAS interbody device and its specialised surface treatment," comments Sutcliffe. Increasing demand for posterior spinal fusion procedures will strain healthcare systems, Boston Scientific announces three-month data from SOLIS trial at NANS. The Endoskeleton lumbosacral interbody fusion devices are indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1; Endoskeleton cervical interbody fusion devices are indicated for use for anterior cervical interbody fusion in skeletally mature patients with degenerative disc The construct does not extend beyond the anterior border of the disc space to prevent disruption to adjacent anatomical structures. These designs support anterior cervical and anterior, posterior, oblique, and lateral approaches to the lumbar spine. Healthcare Professionals To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Home; App Suite; . Intervertebral Fusion Device With Integrated Fixation, Lumbar. (UPDATED 2022): +20 Expandable Lateral Cages to Know! The design incorporates windows through the implant to permit visualization of the graft material, and over time, formation of new bone. A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or tensioning of a nut during a surgical procedure. We feel that we are well positioned to continue to increase our market share and meet the growing need of spine surgeons looking for innovative interbody implants that create a superior osteogenic environment for their patients., Write to us Ghost Productions provided Titan Spine with an technique animation of its Endoskeleton device. The Northwestern McCormick School of Engineering researchers [], Stratasys today announced it signed an agreement with Ricoh to provide on-demand 3D-printed anatomic models for clinical settings. $12M Verdict Against DePuy Synthes for Spinal-Fusion Patent Infringement. Each site will have a predetermined bonegraft extender to be used in all enrolled subjects at that site. All rights reserved. Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification, M/L x A/P= 14 x12 mm (Small), 16 x14 mm (Medium), or 18 x16 mm (Large), L = 22 mm (0 or 4), 26 mm (0 or 4), or 31 mm (0 only), M/L x A/P= 32 x21 (Standard), 36 x 24 (Large), or 40 x 27 mm (X-Large), M/L x A/P= 32 x21 (Standard), 36 x 24 (Large). An integrated collar prevents screw backout while allowing variable angle screw placement and for the screws to act independently from the implant. Any other concurrent medical disease that might impair normal healing process. One of the first implantations of the Endoskeleton TAS was conducted by Dr. RobertHenderson, Orthopedic Surgeon with Dallas Spine Care in Dallas, Texas. . Each year, Medical Design & Outsourcingranks the worlds largest 100 medical device companies based on annual revenue. [], A research team at City University of Hong Kong (CityU) says it engineered a breath-to-charge electrostatic face mask. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. The combination of immediate stabilization and the osteoinductive properties of the implants micro and nano textures represent a significant advance in spine surgery. The Endoskeleton TAS incorporates the same macro, micro, and nano surface textures as the companys Endo TA ALIF device, which has been shown to elicit a superior osteogenic response in comparison to other commercially available interbody materials. Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. Degenerative Disc Disease, Spondylolisthesis, Device: TLIF with Titan TT/TO interbody cage. Insert pedicle screws more precisely and safely without a robot or navigation system? Get more details on current Medtronic interbodies. This is a reusable device. Therapies & Procedures Anti-expulsion texturing on superior and inferior surfaces. Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. Designed to Help Streamline Workflow and Placement For questions they contact Jane Rodd Senior AQ/RA Manager at 262-242-7801. In the opinion of the treating surgeon, must already be a qualified candidate for lumbar fusion surgery including 6 months of conservative care prior to surgical intervention. Spine J. The Endoskeleton TT is a titanium alloy interbody device designed to aid in the fusion of 1 or 2 contiguous levels between L2 and S1 through a TLIF.This device features a surface treatment that includes a combination of textures at the macrolevel and the microlevel. I look forward to adding the TAS to my practice., Kevin Gemas, President of Titan Spine, commented, The addition of the EndoskeletonTAS to our product line now allows us to address approximately 90% of the interbody market that is approaching $1 billion in domestic annual sales. Founded in 2006, the company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. The Endoskeleton TAS incorporates the same macro, micro, and nano surface textures asthe companys Endo TA ALIF device, which has been shown to elicit a superior osteogenic response in comparison to other commercially available interbody materials. Titan Spine is touting the results of a new study demonstrating a reduced subsidence rate and overall subsidence amount of its Endoskeleton TA device compared to a commercially available PEEK device. www.titanspine.com, 1985 - 2023 BioSpace.com. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03910309. I was particularly impressed with the purchase of the screws and how the roughened surface of the implant prevented the device from moving during screw insertion, said Dr. Geisler. Email: [emailprotected] ), Osteoporosis defined as a DEXA bone density measurement T score 2.5 (Necessity for DEXA scan will be determined by investigator's standard of care). Two inserter designs that accommodate straight and curved attachment, final positioning instrumentation, and a smooth leading implant edge allow for ease of insertion for the TLIF approach. Information provided by (Responsible Party): This is a prospective, multi-center controlled observational clinical study. Titan Spine Previous history of fusion surgery at the index level(s). Surgeon Sentenced to 5 Years in Prison for Accepting Illicit Payments to Perform Spinal Surgeries at Corrupt Hospital. Interestingly the company does not state whether it has CE mark approval for the device, although we note they are exhibiting at Eurospine in Milan this week. Two grit-blasted anti-backout or standard screws provide immediate mechanical stability. Titan is the first to gain FDA nanotechnology clearance for spine. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. TEL: +44 (0)20 7736 8788 The regulatory clearance is the fifth approval for the company and supplements its current line of TLIF, PLIF, ALIF, and cervical interbody implants. Choosing to participate in a study is an important personal decision. With an updated browser, you will have a better Medtronic website experience. Titan Original Surface wins the IMAST Whitecloud Award for Best Basic Science. Read our, ClinicalTrials.gov Identifier: NCT03910309, A Prospective Investigation Comparing Bone Graft Extenders in Transforaminal Interbody Fusions (TLIF) With an Acid Etched Titanium Implant: A Clinical Outcomes and Cost Analysis, 18 Years to 75 Years (Adult, Older Adult), Daly City, California, United States, 94051, degenerative disc disease, spondylolisthesis, Pain measured by VAS [TimeFrame:2 years], Function measured by oswestry disability index [TimeFrame:2 years], Success of fusion [TimeFrame:3 months, 6 months, 12 months, 24 months], Be 18-75 years of age, and skeletally mature. Advised consignees to complete and return the enclosed response form. Any subject determined to ALREADY be a candidate for 1 or 2 level transforaminal interbody fusion surgery, Fusion will be assessed by AP/Lat Flex/Ext radiographs. Engineers are the straw that stirs medtechs drink (apologies to Reggie Jackson). Have clinical and radiological evidence of degenerative disc disease at one or two levels of the lumbar spine between L2-S1. July 2014 I am pleased Titan has added the supplemental fixation feature to its ALIF device that I have been using with great success to date. Front Bioeng Biotechnol. Medical Devices companies use Gridlex Zip Help Desk, Customer Services, Shared Mailbox and Ticketing system to manage Medical Device customer support, quality, safety, complaints and ordering, and other operations, Hospital Reimbursement & Quality Outcomes, TITAN SPINE LLC - ENDOSKELETON TAS : Product Information, TITAN SPINE LLC - ENDOSKELETON TAS : Product Code Information, Labeling does not contain MRI Safety Information. Titan completes the first nanoLOCK case. About the Company Titan Spine, LLC is a privately-owned medical implant surface technology company in Mequon, Wisconsin that is focused on the design and manufacturing of proprietary interbody fusion devices for the spine. Update my browser now. 2015 Mar; 40(6): 399-404. Endoskeleton is an anterior vertebral body replacement device. Solutions . It also actively monitors the healing process and harmlessly dissolves with its electrodes into the body once no longer needed. Medical Design and Outsourcing. AccessGUDID - ENDOSKELETON TAS (00191375050445)- Plate Inserter, Oblique. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together. The device is typically made of metal and/or synthetic material (e.g., polysulphone) and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. (G]6/o7Y|>y*\tMJ}f+)W. Designed to Help Facilitate a Smooth and Accurate Placement Interbody Products Banik, B., Riley, T., Platt, C., Brown, J. Check your inbox or spam folder to confirm your subscription. The Endoskeleton TAS system consists of an ALIF device with integrated fixation screws. Email: [emailprotected] BIBA Medical, Europe526 Fulham Road, Fulham, London, SW6 5NR Endoskeleton TAS Interbody System and Endoskeleton TAS Hyperlordotic Interbody System implants are available in a variety of anterior lumbar interbody fusion (ALIF) sizes with a variety of lordotic angles to accommodate patient anatomy. How are the Top Spine Companies performing in 2022 so far? Endoskeleton TA Device / Titan Spine. Full Range of Sizes M/L x A/P= 30 x11 mm or 35 x11 mm Globus Medical Reports Fourth Quarter and Full Year 2022 Results, Features three integrated grit-blasted screws for immediate mechanical stability; allow for up to 10 of medial/lateral or anterior/posterior angular variation, Unique texture of both cage and screw surfaces helps secure device in place upon implantation and helps to prevent screw back-out, Available in thirty-six sizes for increased surgeon choice and improved anatomical fit. The regulatory clearance is the fifth such approval for the company and supplements its current . You have reached the maximum number of saved studies (100). Services may be provided by Western Union Financial Services, Inc. NMLS# 906983 and/or Western Union International Services, LLC NMLS# 906985, which are licensed as Money Transmitters by the New York State Department of Financial Services. Titan introduces its first generation surface technology for titanium interbodies to the market. 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Years in Prison for Accepting Illicit Payments to Perform spinal Surgeries at Corrupt Hospital, multi-center controlled observational study.