The FDA today approved the Subcutaneous Implantable Defibrillator (S-ICD) system from Cameron Health. The device is the first ICD that does not require a lead that connects directly to the heart and therefore does not need to be guided with x-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage…
Cameron Health’s Subcutaneous ICD Sails Through FDA Advisory Panel
April 26, 2012 by 1 Comment
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…
FDA Posts Results of Cameron Subcutaneous ICD Pivotal Trial
April 23, 2012 by Leave a Comment
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…
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