Becker's ASC Review

Jan_Feb_2020_Ortho Pull Out_clean

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Orthofix products or services referenced herein are trademarks or registered trademarks of Orthofix Medical Inc. and its group of companies. Any rights not expressly granted herein are reserved. OFS-AD-2016.1 Becker's © Orthofix Holdings, Inc. 12/2019 Orthofix.com BoneGrowthTherapy.com M6Disc.com CervicalStim ™ Spinal Fusion Therapy CONSTRUX ™ Mini PTC PEEK Titanium Composite Spacer System Trinity ELITE ™ Allograft with Viable Cells M6-C ™ Artificial Cervical Disc The CONSTRUX Mini PTC Spacer System utilizes proprietary technology to securely combine PEEK and titanium into a single interbody solution to leverage the advantages of both materials. PTC is designed with an optimized 3D endplate porosity and pore size to allow for bone ingrowth. PTC also features a PEEK core for a bone-friendly modulus and allows for intra/postoperative imaging without distortion as compared to other metal designs on the market. Trinity ELITE allograft provides the attributes of autograft with versatile handling in FiberLock ™ technology. Exclusively processed by MTF Biologics, validated processing methods are tailored to retain the inherent growth factors and maintain cell health. With ten years on the market and over 200,000 implants, Trinity allografts provide a strong history of clinical results. 3-7 The M6-C artificial cervical disc is a next-generation option for people needing disc replacement as an alternative to spinal fusion. This unique product is designed to mimic the natural disc's structure and movement. The M6-C disc is the only disc featuring an artificial nucleus and annulus that work together to replicate the spine's natural range of motion. Orthofix Cervical Solutions 1. Foley KT, Mroz TE, Arnold PM, et al. Randomized, prospective, and controlled clinical trial of pulsed electromagnetic field stimulation for cervical fusion. Spine J. 2008;8(3):436-442 2. PMA P030034. December 2004 3. Musante et al., Journal of Orthopaedic Surgery and Research (2016) 11:63 4. Jones et al., Foot & Ankle International (2015) 1-9 5. Loveland et al., Journal of Stem Cell Research and Therapy (2-17) 7:10 6. Vanichkachorn et al., Eur Spine J (2015). 7. Peppers et al., Journal of Orthopaedic Surgery and Research (2017) 12:67 *Compatible only with US devices The CervicalStim ™ device is indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion; there are no known contraindications. Do not use this device if you have a cardiac pacemaker or defibrillator. Remove the device prior to any imaging procedures. The safety of this device for use on patients who are pregnant or nursing has not been established. Adverse effects may include increased pain, numbness and tingling, headache, migraines and nausea; these effects may or may not be directly related to use of the device. Full prescribing information can be found in product labeling on our patient education website www.BoneGrowthTherapy.com or by calling Patient Care at 1-800-535-4492. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Brief Prescribing Information: The M6-C ™ Artificial Cervical Disc is indicated for reconstruction of the disc following single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 – C7. The M6-C Artificial Cervical Disc is implanted via an anterior approach. Warning: The M6-C Artificial Cervical Disc should only be used by surgeons who are experienced in the surgical procedure and have undergone adequate training with this device. A lack of adequate experience and/or training may lead to a higher incidence of adverse events, such as vascular or neurological complications. Patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device including the avoidance of heavy lifting, repetitive bending, and prolonged or strenuous activity initially and for a period of weeks to months depending on the individual patient's progress and the stability and functioning of the implant. Potential adverse effects of the device on health include paralysis or death. Read the full prescribing information for important contraindications and all warning, precautions, and instructions for use. Full prescribing information can be found at M6disc.com or by calling 1-888-298-5700. The CervicalStim device is the only bone growth stimulation therapy approved by the FDA as a noninvasive, adjunctive treatment option for cervical fusion in patients at high risk for non-fusion. 1,2 The CervicalStim devices are accompanied by the STIM onTrack ™ mobile app* that engages patients in their recovery process and enables physicians to remotely view patient adherence to their prescription.

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