FDA Approval for Medtronic Viva® Cardiac Resynchronization Therapy-Pacemaker

Medtronic, Inc. has announced the U.S. FDA approval of its newest cardiac resynchronization therapy-pacemaker, Viva® CRT-P, for indicated patients with heart failure or atrioventricular (AV) block. The system gained CE mark approval for European marketing in May this year.

Background

The Viva CRT-P includes the Medtronic-exclusive AdaptivCRT® algorithm, which preserves normal heart rhythms and automatically adjusts to the patient’s needs, creating a customized therapy for each patient. Medtronic says its system utilises the only algorithm demonstrated to improve heart failure patients’ response to the therapy and reduce the risk of atrial fibrillation, or AF (as compared to conventional biventricular therapy). Recent data also show the AdaptivCRT algorithm reduced 30-day hospital readmissions for heart failure by 47 percent and AF-related healthcare utilizations by 55 percent – important benefits since heart failure is a costly problem and represents a leading cause of 30-day hospital readmissions.

Viva CRT-P also features advanced diagnostics tools, such as OptiVol® Fluid Status Monitoring and Cardiac Compass® Report, which provide claimed unmatched levels of insight into patients’ physiological condition. These tools are demonstrated to identify patients at risk for rehospitalization within 30 days of discharge, a critical quality measure.

Physician comments 

“With the AdaptivCRT algorithm, Viva CRT-P is personalized to the individual patient, adjusting to their needs minute-by-minute,” said Daniel Lustgarten, M.D., medical director, Cardiac Electrophysiology Research Laboratory, Fletcher Allen Cardiology, and associate professor, University of Vermont College of Medicine. “With this important new system, patients may respond better to cardiac resynchronization therapy, allowing them to resume daily activities and avoid additional hospitalizations.”

Company comments 

“Our aim is to help people living with heart failure by making cardiac resynchronization therapy even better, through research and improved therapies,” said David Steinhaus, M.D., vice president and general manager, Heart Failure, and medical director for the Cardiac Rhythm and Heart Failure Management business at Medtronic. “The addition of Viva CRT-P to our U.S. portfolio reinforces our commitment to making CRT treatment even more powerful by improving care for patients, reducing complications and ultimately reducing costs.”

Source: Medtronic, Inc.

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