FDA approves Medtronic's Consulta and Syncra pacemaker systems

Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food & Drug Administration (FDA) has approved its Consulta^® and Syncra^™ cardiac resynchronization therapy-pacemaker (CRT-P) systems. Consulta is the first CRT-P that includes Medtronic's exclusive OptiVol^® Fluid Status Monitoring, which 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, 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. Shipments of Consulta and Syncra 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, TX. "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 are the most comprehensive cardiac resynchronization therapy-pacemaker systems offered by Medtronic, providing 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 Consulta and Syncra systems include the same technology, they have differentiating features. Consulta includes Medtronic's exclusive 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.

"We are pleased to offer two unique, next-generation CRT-P options, which provide top-of-the-line features that may benefit hundreds of thousands of heart failure patients and the physicians who treat them," said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "These new innovations in the CRT space confirm our commitment to the development of novel, best-in-class cardiovascular technologies that are backed by industry-leading clinical research."

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 by sending 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. Cardiac resynchronization therapy is intended to complement standard drug treatment, and dietary and lifestyle modifications.

Heart failure, which is typically a late manifestation of one or more cardiovascular disease, affects more than 22 million people worldwide, and accounts for nearly $80 billion in cost each year worldwide. It is also a leading cause of hospitalization among people aged 65 years and older, and admissions for its symptoms have increased by 15 percent during the past 20 years.