Technology | March 28, 2011

FDA Approves Two Cardiac Resynchronization Therapy-Pacemaker Systems

March 28, 2011 – The U.S. Food and Drug Administration (FDA) has approved two new cardiac resynchronization therapy-pacemaker (CRT-P) systems. The Consulta and Syncra CRT-P systems, from Medtronic, are the first to include OptiVol Fluid Status Monitoring.

The feature identifies patients at risk for worsening heart failure before symptoms develop.

Additionally, both Consulta and Syncra are the first CRT?Ps that include Leadless ECG Waveform. Together with the Medtronic CareLink Network device data monitoring system, the systems offer the possibility of remote follow?up in heart failure patients implanted with these devices. Shipments will begin immediately.

“Atrial arrhythmias are the number one cause of reduced cardiac resynchronization therapy; therefore, there is a real need for next?generation devices that can deliver lifesaving CRT in this patient population,” said Robert Canby, M.D., Texas Cardiac Arrhythmia and Seton Medical Center, Austin, Texas. “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.”

Both next?generation systems provide fully automatic capabilities and adaptive therapies that help to ensure CRT, even during atrial fibrillation, and enable physicians to monitor their heart failure patients in the office or remotely. Additionally, both systems include unique programming flexibility to avoid phrenic nerve stimulation, which helps prevent the need for more invasive surgical approaches.

While both systems include the same technology, they have differentiating features. Consulta includes the company’s OptiVol Fluid Status Monitoring, as well as Complete Capture Management, which monitors and adjusts to patient needs automatically and can positively impact device longevity and reduce in?office testing.

Cardiac resynchronization therapy (CRT), also known as bi?ventricular pacing, is a treatment for heart failure that uses an implantable device to improve the pumping efficiency of the heart. A cardiac resynchronization therapy?pacemaker is a stopwatch?sized device implanted in the upper chest to resynchronize the contractions of the ventricles. It sends tiny electrical pacing impulses to the heart muscle via leads (thin wires) to help the heart pump blood throughout the body more efficiently, reduce symptoms and help decrease mortality. CRT is intended to complement standard drug treatment, and dietary and lifestyle modifications.

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