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.

For more information: www.medtronic.com

Related Content

anabolic steroid abuse, ARVC, arrhythmia, stroke, British Cardiovascular Society conference
News | Cardiac Diagnostics| July 01, 2016
Research has already shown that taking anabolic steroids is associated with high blood pressure and an increased risk...
St. Jude Medical, CE Mark, SyncAV CRT, MultiPoint Pacing, CardioStim 2016
Technology | Cardiac Resynchronization Therapy Devices (CRT)| June 28, 2016
St. Jude Medical Inc. announced CE Mark approval and launch of SyncAV CRT software, designed to build upon the company’...
atrial fibrillation, stroke risk, aspirin vs blood thinners, JACC study
News | Antiplatelet and Anticoagulation Therapies| June 24, 2016
More than 1 in 3 atrial fibrillation (AF) patients at intermediate to high risk for stroke are treated with aspirin...
Biotronik, CardioStim 2016 Innovation Award, MRI AutoDetect, Ilivia ICDs
News | EP Lab| June 23, 2016
Biotronik announced it was the winner of the Cardiostim Innovation Award in the category “Best Practice Improvement”...
Zoll LifeVest wearable defibrillator, WEARIT-II Registry results, CardioStim EuroPace 2016
News | Defibrillator Monitors| June 21, 2016
Zoll Medical Corp. announced that patients experience a high one-year survival rate following use of the LifeVest...
News | Implantable Cardioverter Defibrillators (ICD)| June 14, 2016
Medtronic plc announced results from several feasibility studies evaluating a new approach to implantable cardioverter...
Medtronic, Micra TPS pacemaker, Global Clinical Trial, Cardiostim 2016
News | Pacemakers| June 09, 2016
Medtronic plc announced new results from the Medtronic Micra Transcatheter Pacing System (TPS) Global Clinical Trial in...
EPIC Alliance, women in electrophysiology, cardiac rhythm management, Cardiostim 2016 conference
News | EP Lab| June 08, 2016
Physicians presented original research and real-world clinical evidence at a symposium organized by the...
Medtronic, Micra TPS, transcatheter pacing system, pacemaker, Jersey Shore University Medical Center, New Jersey first
News | Pacemakers| June 06, 2016
Jersey Shore University Medical Center, part of Meridian CardioVascular Network, is the first hospital in New Jersey to...
female patients, atrial fibrillation, blood thinning therapy, AFDST, decision support tool, Cincinnati
News | Antiplatelet and Anticoagulation Therapies| June 02, 2016
Female atrial fibrillation patients are less likely than their male counterparts to receive blood thinning therapies to...
Overlay Init