FDA clears Medtronic CRT-P

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The FDA has approved Medtronic’s Consulta and Syncra cardiac resynchronization therapy-pacemaker (CRT-P) systems.

Consulta includes Medtronic‘s OptiVol fluid status monitoring, which seeks to identify patients at risk for worsening heart failure before symptoms develop. Additionally, both Consulta and Syncra include Leadless ECG Waveform, which together with the Medtronic CareLink Network device data monitoring system, offer the possibility of remote follow-up in heart failure patients implanted with these devices.

The Minneapolis-based company said it would begin shipping immediately.