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FDA approves Medtronic’s Consulta, Syncra pacemaker systems

Medtronic says both Consulta and Syncra include technology that allows for remote follow-up of heart patients implanted with the stopwatch-sized devices.

Medtronic Inc. has started shipments of its newest line of pacemaker systems Consulta and Syncra now that the devices have won U.S. Food and Drug Administration approval.

Fridley-based company said Wednesday that both Consulta and Syncra include technology that allows for remote follow-up of heart patients implanted with the stopwatch-sized devices. The pacemaker systems link remotely to the Medtronic CareLink Network device monitoring system.

“These new innovative technologies allow physicians to proactively manage their heart failure patients and offer cutting-edge features that contribute to patient safety and physician ease-of-use,” Dr. Robert Canby, of Texas Cardiac Arrhythmia and Seton Medical Center in Austin, said in a news release.

The Consulta system incorporates additional features. Consulta has OptiVol Fluid Status Monitoring, which identifies patients at risk for worsening heart failure before symptoms develop, and Complete Capture Management, which monitors and then automatically adjusts to patient needs.

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FDA approval of Consulta, Syncra and other Medtronic devices was held up in recent months as the medical technology company resolved FDA warning letter issues involving some of its manufacturing facilities.