April 27th, 2012
Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel
Larry Husten, PHD
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 […]
April 23rd, 2012
FDA Posts Results of Cameron Subcutaneous ICD Pivotal Trial
Larry Husten, PHD
In preparation for Thursday’s meeting of the FDA’s Circulatory System Devices advisory panel, the FDA has released the results of the pivotal trial for the Cameron Health subcutaneous ICD system (S-ICD). The results have not been previously available. Unlike previous ICDs, which require threading a transvenous lead to the heart, the S-ICD system contains no leads to connect the device to […]
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