Medtronic’s Newly CE Marked Cardiac Resynchronisation Therapy Devices Preserve Normal Heart Rhythm

In short

Medtronic, Inc. has announced the CE Mark approval 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 the company says 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.

Background

Defibrillation therapy in heart failure patients is known to be more effective and demonstrate improve patient response if it can be synchronised to the individual’s intrinsic electrical rhythms which control cardiac pacing.  Until now, attempts to improve patients’ response rates with device timing optimisation (echocardiographic-based or device-based) have resulted in modest incremental clinical benefits in this area. Furthermore these optimisation methods are complicated, time-consuming and expensive, and they only measure one point in time rather than continually adjusting to patient needs.

Medtronic’s 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.

Findings from a new study, which will be presented next week at the European Society of Cardiology’s ESC Congress 2012 in Munich, show that patients’ response to therapy with AdaptivCRT was 12 percent (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 percent.

In addition, patients in the AdaptivCRT study with the algorithm experienced a reduction in right ventricular pacing by 44 percent, thus reducing unnecessary right ventricular pacing and extending the longevity of CRT-D devices.

Clinician comments

“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 don’t experience symptomatic improvement,” said Jagmeet P. Singh, M.D., Ph.D., director of the cardiac resynchronization program at Massachusetts General Hospital in Boston. “The new AdaptivCRT technology is designed to improve CRT response by automatically providing a new way to deliver and dynamically optimize therapy, offering each patient individualized treatment.”

Company comments 

“The Viva/Brava family of devices offers clinicians and their patients a new approach to CRT treatment, providing therapeutic benefit and individualized care for patients,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “AdaptivCRT enables us to deliver CRT differently, allowing for greater efficiency and ensuring maximum treatment response.”

Regulatory status

AdaptivCRT is only available in the United States for investigational use.

Source: Medtronic Inc.