HealthDay News — The FDA has approved the first defibrillator that doesn’t require a hard-wired connection to the heart, the agency announced in a press release.
Standard defibrillators deliver electric pulses using a lead that’s inserted directly into the heart via a vein using fluoroscopy. The newly approved device, called the subcutaneous implantable cardioverter-defibrillator system (S-ICD, Cameron Health), uses a lead that’s implanted just below the skin along the bottom of the rib cage and breast bone, and requires no x-ray guidance.
S-ICD is indicated for patients at risk of ventricular tachyarrhythmias who do not require a pacemaker or pacing therapy.
Approval was based on a 321-person study in which 78 cases of spontaneous arrhythmia in 21 patients were converted to normal rhythm during a six-month follow-up period. A total of 304 patients were successfully implanted with the device, but only those needing a replacement or revision of an existing transvenous ICD were included.
Inappropriate shocks, discomfort, system infection and electrode movement that required repositioning were the most common side effects.
A five-year post-marketing study involving 1,616 patients is currently underway to evaluate the defibrillator’s long-term safety and effectiveness, as well as any gender-specific differences in outcomes.