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Subcutaneous ICD wins FDA approval
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Cameron Health’s subcutaneous implantable cardioverter defibrillator system received regulatory approval from the FDA for treatment of patients at risk for sudden cardiac arrest, according to a press release.
As part of the approval, the FDA is requiring the manufacturer to conduct a postmarket study to assess the long-term safety and performance of the device and to assess differences in effectiveness across sexes. The study will follow 1,616 patients for 5 years.
The agency based approval of the device on a study involving 321 patients, 304 of whom were successfully implanted with the subcutaneous ICD (S-ICD) system. At the time of implantation, the researchers tested the device’s efficacy by inducing arrhythmias. According to data, the system successfully converted all abnormal heart rhythms that it detected back to normal rhythms.
Researchers followed patients for 6 months after implantation, during which time the device detected and recorded 78 spontaneous arrhythmias in 21 patients. All arrhythmias were successfully converted back to normal by the device or resolved on their own. Because the S-ICD system memory stores data from only the 22 most recent arrhythmia episodes, there may have been other detected episodes that could be analyzed by investigators.
The most common complications experienced during and after implantation with the S-ICD system included inappropriate shocks, discomfort, system infection and electrode movement requiring repositioning. At the end of 6 months, 90% of patients had no complications, according to the release.
Data were presented at the Heart Rhythm Society’s 33rd Annual Scientific Sessions.
The S-ICD uses a lead that is implanted just under the skin along the bottom of the rib cage and breast bone. Because the lead is placed under the skin rather than through a vein into the heart, a physician can implant the device without accessing a patient’s blood vessels or heart and without the need for fluoroscopy, according to the release.