Posts Tagged ‘FDA advisory panel’

July 2nd, 2012

Eroding Confidence in ASD Occlusion Devices


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 […]