September 28th, 2012
Subcutaneous ICD Gains FDA Approval
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 by X-ray fluoroscopy. Instead, the S-ICD lead is implanted along the bottom of the rib cage and breastbone.
The S-ICD System has been approved only for patients who do not also require a pacemaker or pacing therapy. The FDA will require Cameron Health to perform a 5-year postmarketing study, which will include 1616 patients, to measure the long-term safety and efficacy of the device and to test whether the device is equally effective in men and women.
“The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine ICD placement procedure is not ideal,” said Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, in a press release. “Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device.”
In April, the FDA’s Circulatory System Devices panel voted 7-1 that the benefits of the S-ICD outweigh the risks in appropriately selected patients. Approval was based on the pivotal 321-patient study in which 304 patients successfully received the S-ICD. During the 6-month follow-up period, the device detected 78 arrhythmias in 21 patients. According to the FDA analysis, all the arrhythmias were terminated by the device or resolved spontaneously. Common complications of the device include inappropriate shocks, discomfort, system infection, and electrode movement.
Earlier this year Boston Scientific acquired Cameron Health for an initial payment of $150 million. Depending on future performance, the price may reach as much as $1.2 billion.
Rick Lange, who served on the FDA’s Circulatory System Devices advisory panel that reviewed the S-ICD, provided the following comment for CardioExchange:
This will be a niche device… it will have a limited role because it’s not suitable for patients who also need or would benefit from pacing therapy. However, it may be particularly suitable for primary prevention of SCD in children or young adults (i.e., those with HOCM, long-QT, RV dysplasia, Brugada syndrome, family history of SCD, etc.), in whom intravascular lead placement is not attractive because of continued growth of the child or concerns about long-term lead complications. The FDA panel insisted that a postmarketing study be performed to ensure that the device appropriately sensed and treated lethal arrhythmias. Early versions of the sensing algorithm needed tweaking.