FDA approves a pair of Medtronic defibrillators to detect, treat atrial fibrillation

Atrial fibrillation can be difficult to diagnose, but patients with untreated AF are 5 times more likely to have a stroke and three times more likely to develop heart failure. Now, the FDA has approved a pair of implantable cardioverter defibrillators (ICD) from Medtronic specifically for previously undiagnosed and/or asymptomatic AF patients, as well the monitoring and treatment of recurrent AF.

Medtronic's Visia AF

This enables physicians to actively monitor and treat patients with suspected AF. Both are single-chamber devices, like most new ICDs implanted in the U.S. The devices are slated to launch early this summer.

"Approximately 75% of ICD patients have no history of atrial fibrillation at the time they receive a device," said Dr. Edward Schloss, director of cardiac electrophysiology at The Christ Hospital in Cincinnati, in a statement. "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. The Visia AF ICDs give physicians a new tool to monitor for AF in patients with VR ICDs, which may allow them to identify and treat AF earlier to potentially help avoid other serious conditions."

The Visia AF comes in standard, as well as an MRI-compatible, versions. The ICDs use a proprietary algorithm to detect AF episodes, capture their frequency and duration and offer information so that doctors can identify and treat it. Neither requires a lead in the atrium of the heart. The Visia AF ICDs received a CE mark last year.

"Early detection of AF is vital to assist physicians in making treatment decisions that can reduce stroke and heart failure risk," said Dr. John Liddicoat, Medtronic SVP and President of the Cardiac Rhythm and Heart Failure division. "These single chamber defibrillators with AF detection capabilities, utilizing our proven Quattro lead--alongside our overall portfolio of AF detection devices - demonstrate our commitment to providing cardiac patients with the latest technology to improve their health."

• here is the release