I am pleased Titan has added the supplemental fixation feature to its ALIF device that I have been using with great success to date. This breakthrough inspired a revolution in surface technology, leading directly to a proprietary combination of textures that altered the interbody fusion market. 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. November 2014 Titan Products. All rights reserved. How will market shares and the Status Quo change in the Spine market? 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. Update my browser now. FULL RANGE OF SIZES Endoskeleton TA Device / Titan Spine. Joe Rowan has retired as CEO and president of Junkosha USA but will remain as an advisor as Mike Winterling takes over as chief operating officer. Increasing demand for posterior spinal fusion procedures will strain healthcare systems, Boston Scientific announces three-month data from SOLIS trial at NANS. Titan gains a Nanotechnology New Technology code from CMS. MIT engineers designed the soft robotic models to be patient-specific, which could help clinicians determine the best implant for an individual. Banik, B., Riley, T., Platt, C., Brown, J. Intuitive instrumentation, and large, open graft windows aid in placement. Spine. I am pleased Titan has added the supplemental fixation feature to its ALIF device that I have been using with great success to date. Also provides the ability to pack additional bone graft material post implantation. Screws include internal hex drive features matched to instrumentation for implantation. Durham, North Carolina-based Isolere Bio develops new and proprietary IsoTag reagents and filtration processes used for the purification and streamlined manufacturing of biopharmaceuticals. Placement on the apophyseal ring helps prevent subsidence. Interbody Technology Titan Spine Endoskeleton TAS Interbody Fusion Device (K163269, S.E. July 2014 Home Any terminal or autoimmune disease including but not limited to HIV infection, rheumatoid arthritis or lupus. Distributors were advised to examine their inventory and quarantine the product. United States: Ghost Productions provided Titan Spine with an technique animation of its Endoskeleton device. Titan Original Surface wins the IMAST Whitecloud Award for Best Basic Science. Designed to Help Facilitate a Smooth and Accurate Placement Human mesenchymal stem cell morphology and migration on microtextured titanium. Robert Henderson, orthopaedic surgeon at Dallas Spine Care in Dallas, Texas, USA, performed one of the first implantations of the Endoskeleton TAS, he commented, I felt the procedure went very well and the surgical technique was simple and straightforward.. Implant designs for a variety of approaches. A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to . Email: [emailprotected] Therapies & Procedures s aux critures et techniques varies Ven 10.03.23. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user. Globus Medical acquires Nuvasive: Our first thoughts on this acquisition! The most comprehensive information guide on ENDOSKELETON TAS - TITAN SPINE LLC including impacted physicians & ROI, Business Case, HEOR & VAC Business & Quality Metrics. The implant system includes integrated fixation (screws) for stabilizing the implants when placed in the interbody space. Why are Sales Reps a key piece in the success of the Globus and Nuvasive merger? All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. 34 All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure. ), 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). Nothing happens financing, manufacturing, approval, help for patients without a well-conceived product. The population will be drawn from an existing patient population per participating site. Titan Endoskeleton TT and OsteoSponge/BMA. 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 Endoskeleton is an anterior vertebral body replacement device. 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. One hundred and fifty (150) subjects will participate in the study at a max of 15 clinical sites. Investigational drug or device use within 30 days. Terms and Conditions | Privacy Policy. indications for use, material, surgical technique, material, surface treatment and dimensions of the subject devices are identical predicate devices. Efficient surgical workflow, intuitive instrumentation, and a smooth leading implant edge allow for easy insertion for the TLIF and PLIF trajectories. The deal expands Minneapolis-based Donaldsons life sciences business. Unique Implant Incorporates Integrated Screws that Prevent the Need for Supplemental Fixation 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 received FDA clearance to commercially release its Endoskeleton TAS system, consisting of an ALIF device with . MedTech 100 is a financial index calculated using the BIG100 companies covered in This device features a surface treatment that includes a combination of textures at the macrolevel and the microlevel. 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 received FDA clearance to commercially release its Endoskeleton TAS system, consisting of an ALIF device with integrated fixation screws. 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. The US Food and Drug Administration has cleared the Endoskeleton TAS system (Titan Spine) for lumbar spine fusion. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. It is a nice option to have for specific spinal pathologies where supplemental posterior stabilization can be avoided. Dr. Fred Geisler, Neurosurgeon with The Chicago Back Institute in Chicago, Illinois, was also one of the first surgeons to implant the device. 04/13/2017) Additional Predicates . For questions they contact Jane Rodd Senior AQ/RA Manager at 262-242-7801. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Devices incorporate Titan Surface Technologies, where superior and inferior surfaces include either Chemtex or nanoLOCK surface treatments (MMN) designed to improve fixation to the adjacent bone. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Study Design Go to Le Gymnase CDCN uvre depuis quarante ans au soutien et au maillage du secteur chorgraphique sur la mtropole lilloise, ainsi que sur le territoire rgional et national. Titan Endoskeleton. Gare. 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. (www.medtronic.com), Filed Under: Anterior Lumbar Interbody Fusion Cages (ALIF). CorMatrix ECM gains FDA approval for Carotid Repair, Successful US implants of ValveXchange two-part heart valve system: Eu trials planned. The Titan Endoskeleton Surface Technology was developed to promote bone growth through cellular interaction. The findings emanate from a dynamic mechanical study assessing subsidence rates of spinal implants during . View this study on Beta.ClinicalTrials.gov, U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The original Titan Endoskeleton surface is supported by a growing body of peer-reviewed literature. Titan interbody solutions accommodate many different patient anatomies. Editor: Anthony Strzalek [emailprotected] AccessGUDID - ENDOSKELETON TAS (00191375050445)- Plate Inserter, Oblique. Three integrated, grit-blasted screws provide immediate mechanical stability. Physicians and Distributors were sent on 7/20/2015 separate Titan "Urgent Medical Device Recall" letters dated July 20, 2015. 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. Home; App Suite; . Information provided by (Responsible Party): This is a prospective, multi-center controlled observational clinical study. One of the first implantations of the Endoskeleton TAS was conducted by Dr. Robert Henderson, Orthopedic Surgeon with Dallas Spine Care in Dallas, Texas. Immediate mechanical stability ) says it engineered a breath-to-charge electrostatic face mask help Facilitate Smooth. Receive Titan Endoskeleton surface Technology was developed to promote bone growth through cellular interaction to HIV,... The data Element Definitions if submitting registration or results information Titan Endoskeleton is! Annual revenue from SOLIS trial at NANS about this study, you or your doctor may contact the research... Boston Scientific announces three-month data from SOLIS trial at NANS says it a... Physicians, hospitals and patients in approximately 160 countries IsoTag reagents and filtration used., and a Smooth leading implant edge allow for easy insertion for the planned.... Anterior lumbar interbody fusion device ( K163269, S.E study research staff using the contacts provided below subjects will Titan! 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