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

Image courtesy of Boston Scientific

Feature | Business| February 10, 2016 | Dave Fornell
After five years of almost constant lobbying efforts and numerous attempts by the U.S.
cardiomyocytes, electrical stimulation, human stem cells, Columbia Engineering

Electrically conditioned human cardiomyocytes. Striated ultrastructure containing troponin ( stained in green) forms around cell nuclei (stained in blue.) Image courtesy of Benjamin Lee, Columbia Engineering

News | Stem Cell Therapies| February 09, 2016
Columbia Engineering researchers have shown, for the first time, that electrical stimulation of human heart muscle...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
caffeine consumption, extra heartbeats, UCSF study, UC San Francisco, Journal of the American Heart Association
News | EP Lab| February 04, 2016
Contrary to current clinical belief, regular caffeine consumption does not lead to extra heartbeats, which, while...
Stereotaxis, Philips, collaboration, Niobe ES remote magnetic navigation system, Allura Xper FD10 cardiovascular X-ray

Niobe ES image courtesy of Stereotaxis Inc.

Technology | Cath Lab| February 04, 2016
February 4, 2016 — Stereotaxis and Philips have signed an addendum pursuant to their existing Development and Coopera
Biotronik, CE approval, Ilivia ICDs and CRT-Ds, ProMRI, MRI AutoDetect
News | Implantable Cardioverter Defibrillators (ICD)| February 03, 2016
Biotronik announced CE approval for its new Ilivia implantable cardioverter defibrillators (ICDs) and cardiac...
Abbott, Kalila Medical, acquisition, electrophysiology offerings

Vado Steerable Introducer Sheath image courtesy of Kalila Medical

News | Ablation Systems| February 02, 2016
Abbott announced that it has acquired private medical device company Kalila Medical Inc. Kalila Medical is a developer...
Allegheny General Hospital, MRI, patients with implantable cardiac devices, safety and effectiveness
News | EP Lab| February 01, 2016
The findings of a major study led by cardiovascular imaging specialists at Allegheny General Hospital (AGH) suggest...
News | EP Lab| January 29, 2016
Diseased hearts may be thrown out of rhythm by structural differences, now visible for the first time, in protein...
Technology | Ultrasound Intra-cardiac Echo (ICE)| January 26, 2016
Conavi Medical Inc. (formerly Colibri Technologies Inc.) has received U.S. Food and Drug Administration (FDA) 510(k)...
Overlay Init