Posts Tagged ‘FDA advisory panel’

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July 2nd, 2012

Eroding Confidence in ASD Occlusion Devices

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The FDA has identified more than 100 cases of cardiac erosion following atrial septal defect occlusion (ASO) device implantation. All were associated with implantation of the AMPLATZER (AGA Medical/St. Jude Medical) or related cribriform ASO devices; none have been reported thus far with the GORE HELEX (Gore Medical) ASO device. Although the estimated occurrence of cardiac erosion […]


May 21st, 2012

Rivaroxaban for ACS Gets Positive FDA Review, but Questions About ATLAS Trial Conduct Persist

The FDA will offer generally positive – but also highly mixed – advice to the FDA’s Cardiovascular and Renal Drugs Advisory Committee when it meets on Wednesday to consider the supplemental new drug application for rivaroxaban (Xarelto, Johnson & Johnson) for use in patients with acute coronary syndrome (ACS) already taking dual antiplatelet therapy. The FDA posted the briefing […]


April 27th, 2012

Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel

The FDA’s Circulatory System Devices panel voted 7-1 on Thursday that the benefits of the Cameron Health subcutaneous ICD system (S-ICD) outweigh the risks in appropriately selected patients. Unlike all previous ICDs, the S-ICD is much easier to implant because it is does not require threading a lead to connect the device to the heart. Panel member Rick Lange […]