Medtronic Viva CRT-P gets FDA approval

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Medtronic has announced the US Food and Drug Administration (FDA) approval of its newest cardiac resynchronisation therapy-pacemaker, Viva CRT-P, for indicated patients with heart failure or atrioventricular block.

The Viva CRT-P includes the Medtronic AdaptivCRT algorithm, which preserves normal heart rhythms and automatically adjusts to the patient’s needs, creating a customised therapy for each patient. It is the only algorithm demonstrated to improve heart failure patients’ response to the therapy1 and reduce the risk of atrial fibrillation (as compared to conventional biventricular therapy)2. Recent data also show the AdaptivCRT algorithm reduced 30-day hospital readmissions for heart failure by 47%3 and atrial fibrillation-related healthcare utilisations (hospitalisations, emergency department or clinic visits) by 55%4 – important benefits since heart failure is a costly problem and represents a leading cause of 30-day hospital readmissions5.

“With the AdaptivCRT algorithm, Viva CRT-P is personalised to the individual patient, adjusting to their needs minute-by-minute,” says Daniel Lustgarten, 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 resynchronisation therapy, allowing them to resume daily activities and avoid additional hospitalisations.”

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% at six months1;
  • Patients with AdaptivCRT demonstrated a 21% reduction in heart failure hospitalisations at one year as compared to historical CRT trials 6;
  • Patients with AdaptivCRT demonstrated a 46% reduced risk of AF2 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 rehospitalisation within 30 days of discharge7, a critical quality measure.

References


1
Birnie D, et al. HeartRhythm. September 2013;10(9):1368-1374.

2 Martin D, et al. Circulation. 2013;128(22S):A17740.

3 Starling RC, et al. Heart Rhythm. 2014;11(5)(suppl):S155.

4 Lemke B, et al. Atrial fibrillation resource use with an adaptive device algorithm. June 2014, Cardiostim, Nice, France.

5 Elixhauser A., Steiner C. Readmissions to US hospitals by diagnosis, 2010. Healthcare cost and utilization project, Statistical Brief #153. Agency for Healthcare Research and Quality. 2013

6 Tarab AD, et al. Value in Health. November 2012;15(7):A349.

7 Whellan DJ, et al. Development of a method to risk stratify patients with heart failure for 30-day readmission using implantable device diagnostics. Am J Cardiol. 2013;111(1):79-84.

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