FDA approves single-chamber ICDs to detect, monitor AF

Medtronic announced that the FDA approved its single-chamber implantable cardioverter defibrillators with the capability to detect and monitor new-onset, asymptomatic AF.

The single-chamber implantable ICDs (Visia AF and Visia AF MRI SureScan, Medtronic) use a proprietary algorithm to detect AF without a lead in the atrium. The device not only treats life-threatening rhythms, but also captures AF burden frequency and duration, allowing physicians to identify AF and tailor treatment to the patient, according to a company press release.

“Approximately 75% of ICD patients have no history of [AF} at the time they receive a device,” Edward J. Schloss, MD, director of cardiac electrophysiology at The Christ Hospital, Cincinnati, said in the release. “After device implant, we’ve seen about 20% of these patients go on to have newly discovered AF. Until now, we haven’t been able to detect these arrhythmias with single-chamber ICD diagnostics.”

If AF is undetected in those cases, the patient is five times more likely to have a stroke and three times more likely to develop HF, according to the release.

According to Medtronic, the Visia AF ICDs include SureScan technology, which is approved for MRI scans anywhere in the body without any positioning restrictions, and SmartShock 2.0, which enables the device to more accurately differentiate between dangerous and harmless rhythms and reduce the inappropriate shock rate.

“The Visia AF ICDs give physicians a new tool to monitor for AF in patients with [single-chamber] ICDs, which may allow them to identify and treat AF earlier to potentially help avoid other serous conditions,” Schloss said in the release.

Disclosure : Schloss reports receiving consulting and speaking fees from Medtronic.