FDA Panel Favors Medtronic’s Bryan Cervical Disc Despite Durability Question
This article was originally published in The Gray Sheet
Executive Summary
FDA's Orthopedic and Rehabilitation Devices Panel overwhelmingly supported approval of Medtronic Sofamor Danek's Bryan artificial cervical spinal disc, while acknowledging that the device's long-term durability is unknown
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Medtronic To Launch Bryan Cervical Disc In July
Medtronic will begin a controlled market release of its Bryan artificial cervical disc in July, the firm announced June 11. The device was approved by FDA May 12
Medtronic To Launch Bryan Cervical Disc In July
Medtronic will begin a controlled market release of its Bryan artificial cervical disc in July, the firm announced June 11. The device was approved by FDA May 12
Research In Brief
CT angiography: Computerized tomographic angiography (CTA) is a safe and effective diagnostic method for ruling out serious cardiovascular disease in patients who come to an emergency department with chest pains, according to the lead author of a long-term study of CTA screening presented May 15 at the Society for Academic Emergency Medicine's annual conference in New Orleans. In the study, led by Judd Hollander, University of Pennsylvania, 481 patients who had no evidence of coronary blockage in a CTA scan were followed for one year. None of the patients had a heart attack or required a coronary revascularization procedure during the follow-up, although 11% were rehospitalized for further cardiac testing. "The ability to rapidly determine that there is nothing seriously wrong allows us to provide reassurance to the patient and to help reduce crowding in the emergency department," Hollander said. According to the Medical Imaging & Technology Alliance, previous research has shown that CTA screening saves $2,500 per patient versus admitting the patient to the hospital for more extensive testing. In a MITA press release, Hollander says: "The evidence now clearly shows that when used in appropriate patients in the emergency department, we can safely and rapidly reduce hospital admission and save money.