The US Food and Drug Administration has cleared the Endoskeleton TAS system (Titan Spine) for lumbar spine fusion. The nanoLOCK surface is the result of this extensive research and represents the new standard in spinal fusion interbody implants. The Company’s line of Endoskeleton® devices, will feature nanoLOCK surface technology, delivering a statistically significant greater amount of the osteogenic and angiogenic growth factors that are critical for bone growth and fusion when compared to PEEK and the company’s current surface. Please refer to package insert for current warnings, precautions, and instructions for use. Effectively the. Totals listed account for all payments during the 2018 calendar year. In addition, the nanoLOCK surface is not created by applying a coating, but rather is formed by a reductive process of the titanium itself. That saw the company offering one-time free replacement of any eligible Titan spinal interbody fusion device if revision surgery is required within the five year warranty period. Required fields are marked *. The TCS utilizes Titan’s proprietary surface technology. ENDOSKELETON ® TAS - SIZING Notice: One or more products are covered by patents. This marks the first clearance of nanotechnology interbody devices by the FDA, which is an acknowledgement to Titan’s leadership in developing nanotechnology for the spine and potentially other orthopedic applications. The Titan Endoskeleton Surface Technology was developed to promote bone growth through cellular interaction. Aggregate totals are shown, including payments to doctors and teaching hospitals. 1. company making payments related to this device in 2018. ENDOSKELETON ® TAS - SIZING SURGICAL TECHNIQUE ENDOSKELETON ® TO DEVICE SIZES ENDOSKELETON ® TT DEVICE SIZES ENDOSKELETONTT/TO ® TT/TO Posterior Interbody Fusion Device for the Lumbar Spine TT/TO Notice: One or more products are covered by patents. This eliminates the potential for delamination, which is a concern for products with a PEEK-titanium interface. Az e-Titán a közlekedési képzések online adminisztrációs rendszere. What we have learned is that there are very specific implant surface topographies, especially at the nano level, that generate the osteogenic and angiogenic responses necessary to drive bone growth required for a robust fusion. It has not been tested for heating, migration, or image artifact in the MR environment. $762K. Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, has received U.S. FDA 510(k) clearance from for its Endoskeleton® line of interbody fusion implants featuring its next-generation nanoLOCK™ surface technology. Now the company tells us it has received U.S. FDA 510(k) clearance from for its Endoskeleton® line of interbody fusion implants featuring its next-generation nanoLOCK surface technology. Companies Making Payments Related to this Device. Note: We have made some effort to normalize the data and eliminate duplicates, but the data is primarily as it has been reported by the companies to the Centers for Medicare and Medicaid Services. Scanning a patient who has this device may result in patient injury. A tanulók a rendszeren keresztül vehetnek részt az eduKRESZ e-learning tananyagokkal megvalósuló elméleti képzésben, és teljes körű online tanulói ügyintézést végezhetnek. Companies Making Payments Related to this Device. 0 . doctors receiving payments in 2018. Titan Spine is a frequent visitor to our pages, most recently hitting the headlines with its mold-breaking satisfaction guarantee. Titan Spine, LLC is celebrating the receipt of a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the release its Endoskeleton TCS, an interbody fusion device for the cervical spine with integrated fixation. 1. company making payments related to this device in 2018. This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting new bone growth, encouraging natural production of bone morphogenetic proteins (BMPs) and creating the potential for a faster and more robust fusion. Titan Spine will offer its complete line of titanium devices for interbody fusion spine surgery procedures in the cervical and lumbar spine now with nano-scale features that offer added benefits to patients.”, Peter Ullrich, MD, former spine surgeon and Chief Executive Officer of Titan Spine, remarked, “Receiving FDA approval for our next-generation surface technology is a tremendous milestone for Titan Spine. The safety of Endoskeleton TO Interbody Fusion Device in the MR environment is unknown. teaching hospitals receiving payments in 2018. Titan Spine Endoskeleton TT/TO Study. This site includes data published by the Centers for Medicare and Medicaid Services on June 28, 2019. We will continue to innovate the spinal interbody market through close collaboration with leading academic pioneers in material science and biomedical engineering and look forward to future enhancements to our Endoskeleton® devices.”, Your email address will not be published. To purchase bulk data, please visit the ProPublica Data Store. TITAN ENDOSKELETON. The Titan Spine Endoskeleton TO Interbody Fusion Device has not been evaluated for safety and compatibility in the MR environment. Read our disclaimer for details. An integrated collar prevents screw backout while allowing variable angle screw placement and … $762K. ClinicalTrials.gov Identifier: NCT03910309: Recruitment Status : Terminated First Posted : April 10, 2019. Titan Spine offers a full line of interbody fusion devices featuring its surface technology. The study looked at 77 patients with a mean age of 46 years who underwent an ALIF procedure using the Endoskeleton interbody device. If you spot an error, please let us know at [email protected]. TITAN ENDOSKELETON. It has not been tested for heating, migration, or image artifact in the MR environment. Aggregate totals are shown, including payments to doctors and teaching hospitals. 2014 Prix Galien Award for Best Medical Technology goes to Stryker for Neuro Clot Remover, NASS Sees Launch of First New MIS Fully Articulating Expandable Spacer for Spinal Fusion. 0 . The Company’s line of Endoskeleton® devices, will feature nanoLOCK surface technology, delivering a statistically significant greater amount of the osteogenic and angiogenic growth factors that are critical for bone growth and fusion when compared to PEEK and the company’s current surface. TITAN ENDOSKELETON TCS. ENDOSKELETON ® TAS - SIZING SURGICAL TECHNIQUE ENDOSKELETONTAS ® TAS Anterior Fusion Device for the Lumbar Spine with Integrated Fixation TAS BONE SCREW SIZES 2300-5525 / 25mm 2300-5530 / 30mm 2300-6525 / 25mm 2300-6530 / 30mm 5.5mm Diameter 6.5mm Diameter Notice: One or more products are covered by patents. NJ. EGG HARBOR TOWNSHIP, Barbara Boyan, Ph.D., Dean of the School of Engineering at Virginia Commonwealth University and an investigator in various Titan Spine studies, said, “This new surface technology further enhances Titan’s current surface and is the result of extensive research in how to create a significantly greater amount of nano-scaled textures that we have shown to be important for the osteogenic response necessary for fusion. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. My team is proud to collaborate with Titan Spine to help develop such a differentiated technology that is truly designed to benefit both patients and surgeons.”, Paul Slosar, M.D., Chief Medical Officer for Titan Spine, commented, “Our new surface technology represents a significant technological breakthrough in treating patients that require interbody fusion. Approach: Anterior Cervical. The Endoskeleton TAS system consists of an ALIF device with integrated fixation screws. The Titan Spine Endoskeleton TCS Interbody Fusion Device has not been evaluated for safety and compatibility in the MR environment. The Endoskeleton’s unique surface has been shown in published cellular research to stimulate improved osteoblast differentiation to support fusion. Our clinical data further substantiates those findings, and demonstrates the notable positive impact on patient outcomes.” Titan Spine is … The proprietary ENDOSKELETON® interbody devices are designed to promote bony ongrowth, optimize intervertebral stability, allow for increased bone graft material, and permit excellent visualization on … A study of Titan Spine, LLC Endoskeleton titanium interbody cage, presented at the 13th Annual Meeting of the International Society for the Advancement of Spine Surgery, found that the device achieved rapid lumbar fusions. 230 . The safety of Endoskeleton TCS Interbody Fusion Device in the MR environment is unknown. Save my name, email, and website in this browser for the next time I comment. teaching hospitals receiving payments in 2018. This breakthrough inspired a revolution in surface technology, leading directly to a proprietary combination of textures that altered the interbody fusion market. doctors receiving payments in 2018. To purchase the normalized data, please visit the ProPublica Data Store. payments related to this device in 2018. Please refer to package insert for current warnings, precautions, and instructions for use. The nanoLOCK surface topography is far different than what is found on titanium-coated PEEK implants. Integrated Fixation Two grit-blasted anti-backout or standard screws provide immediate mechanical stability. Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, has received U.S. FDA 510(k) clearance from for its Endoskeleton® line of interbody fusion implants featuring its next-generation nanoLOCK™ surface technology. 230 . Archive: Search our older data for payments made by 17 drug companies between 2009 and 2013. teaching hospitals receiving payments in 2018, company making payments related to this device in 2018. Effectively the implant surface technology comprises a unique combination of roughened topographies at the macro, micro, and nano levels. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Scanning a patient who has this device may result in patient injury. Your email address will not be published. payments related to this device in 2018. The nanoLOCK technology will be highlighted at the 2014 North American Spine Society (NASS) Annual Meeting, being held November 12-15, 2014 in San Francisco, Calif., at the Titan Spine booth. Titan says this clearance marks out its Endoskeleton® spinal implants as the first FDA-approved interbody fusion devices to feature nanotechnology. Data, please let US know at [ email protected ] who underwent an ALIF procedure using the ’... Most recently hitting the headlines with its mold-breaking satisfaction guarantee in patient injury, 2019 standard in spinal fusion implants... Procedure using the Endoskeleton interbody device Drug Administration has cleared the Endoskeleton ’ s unique surface been... Of textures that altered the interbody fusion devices to feature nanotechnology or products... Protected ] June 28, 2019 on June 28, 2019 who underwent ALIF... 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