August 28, 2014 — Medtronic Inc. announced the U.S. Food and Drug Administration (FDA) approval of its newest cardiac resynchronization therapy-pacemaker, Viva CRT-P, for indicated patients with heart failure or atrioventricular (AV) block.
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. It is 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 (hospitalizations, emergency department or clinic visits) by 55 percent.
"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."
Key findings from the AdaptivCRT trial and sub-analyses have validated the benefits of the algorithm, including:
- For patients with normal AV conduction, AdaptivCRT showed an increase in CRT response rate of 12 percent at six months;
- Patients with AdaptivCRT demonstrated a 21 percent reduction in heart failure hospitalizations at one year as compared to historical CRT trials; and
- Patients with AdaptivCRT demonstrated a 46 percent reduced risk of AF at two years.
Viva CRT-P also features advanced diagnostics tools, such as OptiVol fluid status monitoring and Cardiac Compass report, which provide 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.
"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."
For more information: www.medtronic.com