T2 ALTITUDE™ Expandable Corpectomy Device features an innovative self locking mechanism that eliminates the need for placing a set screw during surgery. 0000015770 00000 n It is a slowly progressive disorder usually caused by spinal cord compression and ischaemia due to age related changes in the spine. 0000007609 00000 n 0000033940 00000 n Plain film radiograph appears to overestimate fusion success with autograft. This technique details the operative approach is as described by Southwick and Robinson and the use of the Medtronic AsterX expandable corpectomy and ZEVO anterior cervical plate system. and is committed to advancing the treatment of spinal conditions. Infuse Bone Graft consists of two components – recombinant human Bone Morphogenetic Protein-2 solution and a carrier/scaffold for the bone morphogenetic protein solution and resulting bone. The results were: This preclinical study was designed to find the appropriate concentration of rhBMP-2. If the cancer 1.50mg/cc concentration had faster and denser bone formation compared to 0.75mg/cc. M, Operating room time is reduced by approximately 30 minutes and using a conservatively estimated cost of $18/min, the result is a $540 offset. Therapies & Procedures 0000023169 00000 n Elevate. T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEM INDICATIONS. affected vertebral bodies and replace them with the T2 ALTITUDE™ The package insert also matches the sizes of those sized devices that are indicated for use with the appropriate Infuse™ Bone Graft kit. Newer designs allow spinal cages to be expandable—a small cage is implanted (reducing the risk of nerve injury), which expands to a larger size after the implantation is done. Elevate, 脊椎後方固定術に用いるケージデバイスです。ケージ自体に最大13°開大する機構を持ち、椎体間に設置後、腰椎の生理的アライメントに合わせた高さ調整（開大）が行えます。, 販売名: ELEVATEスパイナルシステム　　医療機器承認番号: 22900BZX00107000, メドトロニックソファモアダネック株式会社のスパイン事業部が運営する脊椎脊髄外科医の先生方に情報提供することを目的とした会員制医師向けウェブサイトです。, PEEK部分に埋め込まれたタンタルマーカーにより、X‒rayで確認しながら開大の調整が可能. invasive technologies, known as MAST™1. utilization-related data for customers in a manner that meets 2013 Jun 18;158(12):890-902. 0000015649 00000 n Although asymptomatic degeneration of the cervical spine is common within the aging population, when these changes lead to myelopathy, patients are at risk of motor, sensory and autonomic dysfunction, as well as a reduction in quality of life. 0000027018 00000 n Over 32% in both groups were tobacco users. It may require an additional surgery to harvest iliac crest autograft, including its associated morbidity. 0000034461 00000 n There are four possible answers of which one is correct (or on occasion more correct) than the others. Institution : The Avon Orthopaedic Centre, Bristol ,UK. T2 ALTITUDE™ Expandable Corpectomy Device is fully compatible with the CD HORIZON® SOLERA™ Spinal System. Our content is designed for both Surgeons in independent practice and Surgeons in training. About MedtronicMedtronic, Inc. (www.medtronic.com), and approximately 39% of these injuries are cause by motor vehicle Histology is the most definitive method of determining whether a solid fusion has occurred. J Spinal Disord Tech. 0000023254 00000 n Spinal System, or the CD HORIZON® Spinal System. In addition, the T2 ALTITUDE™ Expandable Corpectomy Device is equipped with the VERIFYI™ Implant Tracking System to enhance hospital efficiencies. The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device implanted via an ALIF approach at a single level from L2-S1 or an OLIF approach at a single level from L5-S1. With an updated browser, you will have a better Medtronic website experience. 0000023849 00000 n The objective of taking these tests is to demonstrate that you have understood all aspects of the assessment and management of patients requiring surgical intevention. The Your dashboard also will contain a record of the time you have spent logged onto and using the site. Several variables are to be considered including; ventral versus dorsal compression, sagittal alignment, focal versus diffuse disease, the presence or absence of radiculopathy or axial pain, age, comorbidities, and surgeon familiarity with each specific procedure. 3 (http://emedicine.medscape.com/article/1264191-overview), 4 (http://www.ninds.nih.gov/disorders/sci/detail_sci.htm), Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50048453&lang=en, Medtronic, Inc.Victor Rocha, 901-399-2401Public RelationsorJeff 0000026564 00000 n The bone morphogenetic protein solution component must not be used without the carrier/scaffold component or with a carrier/scaffold component different from the one described in this document. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Each year, there are more than 150,000 spinal fractures in North America 3. Please refer to the Yale University Open Data Access (YODA) Project website for the specific details around the data management program. 0000023409 00000 n product, a self locking expandable vertebral body replacement cage Expandable Corpectomy Device is to be used with supplemental fixation 0000042996 00000 n Laparoscopic anterior spinal arthrodesis with rhBMP-2 in a titanium interbody threaded cage. Compared to preoperative scores, Infuse bone graft patients indicated a 55% improvement on average. ability to insert the cage from a posterior, anterior or lateral NIM-ECLIPSE© System2. About Medtronic 593 0 obj <> endobj xref 593 72 0000000016 00000 n The model focused on single-level interbody fusion in a rhesus monkey, and the study lasted six months. Infuse Bone Graft eliminates hip pain and the complications related to autograft bone harvest. hospital efficiencies. Spinal & Orthopaedic (UDI) system. 0000001736 00000 n “T2 ALTITUDE™ is a new option for surgeons who perform plate and the opportunity for fusion to occur inside the device. About the Spinal Business at Medtronic Infuse Bone Graft must be applied within 14 days after the initial fracture. 0000026639 00000 n The high patient accountability at each of the time intervals validates the study results. headquartered in Minneapolis, is the global leader in medical technology This T2 ALTITUDE™ Expandable Corpectomy Device comes in multiple sizes, %PDF-1.5 %���� With an updated browser, you will have a better Medtronic website experience. The Infuse™ Bone Graft/Medtronic Interbody Fusion Device is contraindicated for patients with a known hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen, or to other components of the formulation and should not be used in the vicinity of a resected or extant tumor, in patients with any active malignancy, or patients undergoing treatment for a malignancy; in patients who are skeletally immature; in pregnant women; or in patients with an active infection at the operative site or with an allergy to titanium, titanium alloy, or polyetheretherketone (PEEK). The results indicated at 24 months, Infuse Bone Graft fusion rate was 94.5%, a higher percentage than the 88.7% fusion rate of the control group (though statistically equivalent). Fu R, Selph S, McDonagh M, Peterson K, Tiwari A, Chou R, Helfand M. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis. 0000010957 00000 n An electronic version of the package insert may be found at www.medtronic.com/manuals. 0000023878 00000 n Most common levels are C5/6 followed by C6/7; they are associated with the most flexion and extension in the subaxial spine. require additional spinal structural support which is when the T2 1998;11(2);95-101. metastasizes or spreads in the spine, the surgeon may opt to remove the approach and is compatible with Medtronic’s proprietary minimally Warren, 763-505-2696Investor Relations, http://emedicine.medscape.com/article/1264191-overview, http://www.ninds.nih.gov/disorders/sci/detail_sci.htm, http://www.businesswire.com/cgi-bin/mmg.cgi?eid=50048453&lang=en. Cervical spinal cord compression generally arises from protruded degenerate cervical discs, anterior or posterior cervical canal calcification processes, facet joint hypertrophy or ligamentum flavum hypertrophy. trailer <<6687C3612EDF4AA5A72EA6DF7668BC7B>]/Prev 1422423>> startxref 0 %%EOF 664 0 obj <>stream Plain film radiographs suggest 100% fusion rate in both groups.

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