FDA approves afib-detecting Visia ICD from Medtronic

Medtronic (NYSE:MDT) said it won FDA approval for its Visia AF line of implantable cardioverter defibrillators, which are designed to detect and monitor atrial fibrillation symptoms.

Fridley, Minn.-based Medtronic said it plans to have the Visia AF MRI SureScan and Visia AF single-chamber ICDs on the market in early summer. The devices won CE Mark approval in the European Union last October.

“Early detection of AF is vital to assist physicians in making treatment decisions that can reduce stroke and heart failure risk,” cardiac rhythm & heart failure president Dr. John Liddicoat said in prepared remarks. “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.”

“Approximately 75% of ICD patients have no history of atrial fibrillation at the time they receive a device,” added Dr. Edward Schloss of  Cincinnati’s Christ Hospital. “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.”

Medtronic said the devices are also approved for MRI scans under its SureScan label.

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