Medtronic wins FDA nod for 2-level cervical fusion with Prestige LP spine implant

Medtronic (NYSE:MDT) said today that the FDA approved 2-level cervical fusions using its Prestige LP spinal implant. “Medtronic is committed to elevating spine care by combining innovative new technologies with clinical evidence,” Medtronic Spine president Doug King said in prepared remarks. “The Prestige LP Disc is a superior alternative to [anterior cervical discectomy & fusion] and an important motion-preserving option for physicians treating certain patients suffering from two-level cervical disc disease.” Fridley, Minn.-based Medtronic said a 397-patient clinical trial of the Prestige LP device in 2-level procedures showed an overall success rate at 2 years of 81.4% for the Prestige-treated arm, compared with 69.4% for the control cohort. “For my active patients with cervical disc disease at 2 adjacent levels, I want to preserve motion in their necks,” trial investigator Dr. Jeff McConnell, of the Lehigh Valley Hospital in Allentown, Pa., said in a press release. “I choose to use the Prestige LP disc at 2 levels because it provides superior clinical outcomes at 24 months and the titanium ceramic composite material allows post-op assessment and visualization by MRI.” In May, Medtronic launched its Spine Essentials platform for cervical spine fusions, aimed at increasing the efficiency of the most common 1- and 2-level fusion procedures. Just last week the company launched several new c...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Spinal Medtronic Source Type: news

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Conclusions: ACDF utilization increased most rapidly in the outpatient setting, and CON status did not appear to hinder growth. Reimbursement decreased across all settings, with the outpatient setting in non-CON states most affected. Surgeons should be aware of these trends in the changing health care environment.
Source: Journal of Spinal Disorders and Techniques - Category: Surgery Tags: Primary Research Source Type: research
Conclusions: Through this systemic review and meta-analysis, no significant difference was found with regards to fusion rate, postoperative NDI, and VAS between tantalum fusion and iliac crest bone graft in ACDF. More longer-term and randomized studies with large samples are warranted to validate any association found in this study. Level of Evidence: Level II.
Source: Journal of Spinal Disorders and Techniques - Category: Surgery Tags: Systematic Review Source Type: research
AbstractWe suggested operative techniques and indications of robotic neck surgery. To determine operative techniques and the indications for robotic neck surgery, we analyzed treatment outcomes of patients who received robotic neck surgery. Between May 2010 and July 2018, a total of 945 patients with various neck diseases visited Severance Hospital and underwent robotic neck surgery. A variety of approaches, including the retroauricular approach (RA), modified facelift approach (MFLA), transaxillary approach (TA), and transaxillary retroauricular approach (TARA), was used to remove various tumors in the neck. A total of 23...
Source: Journal of Robotic Surgery - Category: Surgery Source Type: research
Publication date: September 2020Source: Interdisciplinary Neurosurgery, Volume 21Author(s): Sang Hoon Jang, Soon O. Hong, Hyeok Jang, Ho-Yeon Lee, Won Chul Choi, Jae Taek Hong
Source: Interdisciplinary Neurosurgery - Category: Neurosurgery Source Type: research
Anterior cervical discectomy with an interbody cage (ACDF) to obtain fusion is a common procedure in cervical spine surgery. Presently, PEEK with (auto)graft is frequently used for interbody fusion although alternative implant technology like 3-D printing titanium has been introduced recently.
Source: The Spine Journal - Category: Orthopaedics Authors: Tags: Clinical Study Source Type: research
CONCLUSION: SSP change after 1- or 2-level ACDF correlates mostly weakly with GSP change. Male gender and osteoporosis were identified as risk factors for global lordotisation following ACDF. PMID: 32158016 [PubMed - as supplied by publisher]
Source: Biomedical Papers of the Medical Faculty of the Univ Palacky Olomouc Czech Repub - Category: Biomedical Science Tags: Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub Source Type: research
Study Design. Retrospective study. Objective. To investigate the associated risk factors for acute respiratory distress after multilevel anterior cervical discectomy and fusion (ACDF) with a focus on the subjective symptom, dyspnea. Summary of Background Data. Acute respiratory distress after ACDF is a relatively common adverse event, the cause of which is usually soft tissue swelling or hematoma. It can result in serious morbidity and requires careful, focused treatment. Methods. We reviewed the records of 532 patients (from January 2014 to August 2018) who had undergone multilevel ACDF surgery. Acute respirato...
Source: Spine - Category: Orthopaedics Tags: CERVICAL SPINE Source Type: research
J Neurol Surg B DOI: 10.1055/s-0040-1701680This video demonstrates the transmastoid suprajugular approach with neck dissection to a solitary fibrous tumor involving the jugular foramen and upper cervical region. This patient was a 39-year-old man who presented with dysphagia and cranial nerve (CN) XI and CN XII palsies. Imaging revealed a large homogenously enhancing lesion involving the jugular foramen and extending into the retropharyngeal space (Fig. 1). Radiographic findings supported a diagnosis of jugular foramen schwannoma. After an initial period of observation, the tumor demonstrated significant growth, and the pa...
Source: Journal of Neurological Surgery Part B: Skull Base - Category: Neurosurgery Authors: Tags: Skull Base: Operative Videos Source Type: research
The current standard of care for clinically N0 patients at risk for cervical lymph node metastases is to undergo neck dissection for completion of staging, as the status of the cervical lymph node basins at the time of diagnosis provides important information about prognosis and treatment planning. However, up to 70% of cN0 patients have no nodal disease and thus underwent unnecessary surgery. The aim of this study is to identify an easily available peripheral blood biomarker that could serve as a marker of occult nodal metastases in cN0 patient with oral cavity squamous cell carcinoma (OCSSCa).
Source: International Journal of Radiation Oncology * Biology * Physics - Category: Radiology Authors: Tags: Poster Theater Presentations Source Type: research
Objective: White cord syndrome is extremely rare and search of the literature has revealed very few cases. Postoperative MR scan revealed hyperintense intrinsic cord signal changes within cord ischemia and ede...
Source: BMC Musculoskeletal Disorders - Category: Orthopaedics Authors: Tags: Case report Source Type: research
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