Viva/Brava cardiac resynchronisation therapy devices get CE mark

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Medtronic has announced it has received CE mark of its Viva/Brava portfolio of cardiac resynchronisation therapy with defibrillation (CRT-D) devices. The family of CRT-Ds features a new algorithm, called AdaptivCRT, which significantly improves heart failure patients’ response rate to CRT-D therapy, as compared to historical CRT trials, by preserving the patients’ normal heart rhythms and by continuously adapting to individual patient needs. AdaptivCRT is only available in the United States for investigational use.

Findings from a new study, which will be presented at the European Society of Cardiology’s ESC Congress 2012 (25–29 August, Munich, Germany) show that patients’ response to therapy with AdaptivCRT was 12% (absolute) higher than in historical CRT trials. In historical trials, heart failure patients had their CRT pacing parameters optimised using time-consuming, echocardiography-guided AV programming, and experienced an average response rate of 66%.

“CRT is a highly effective therapy providing significant survival benefit and reducing hospitalisation rates for patients suffering from heart failure. However, treatment is not a one-size-fits-all approach, as traditionally one-third of these patients do not experience symptomatic improvement,” said Jagmeet P Singh, director of the cardiac resynchronisation programme at Massachusetts General Hospital in Boston, USA. “The new AdaptivCRT technology is designed to improve CRT response by automatically providing a new way to deliver and dynamically optimise therapy, offering each patient individualised treatment.”


Until now, attempts to improve patients’ response rates with device timing optimisation (echocardiographic-based or device-based) have resulted in modest incremental clinical benefits. These optimisation methods are known to be complicated, time-consuming and expensive, and they only measure one point in time rather than continually adjusting to patient needs.


AdaptivCRT optimises simply and automatically as the algorithm continually adjusts to the patient’s dynamic intrinsic conduction, and enables more natural contractions as it synchronises ventricular contraction. In addition, patients in the AdaptivCRT study with the algorithm experienced a reduction in right ventricular pacing by 44%, thus reducing unnecessary right ventricular pacing and extending the longevity of CRT-D devices.


In a randomised Medtronic study, which was published online this month in Heart Rhythm, AdaptivCRT met its pre-specified safety and efficacy endpoints of non-inferiority as compared to the gold-standard comprehensive echocardiography-guided biventricular pacing. These results are part of the PMA submission for AdaptivCRT that is under regulatory review by the FDA.

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