A new Medtronic family of CRT-D (cardiac resynchronization therapy with defibrillation) devices that are the first to feature the company’s AdaptivCRT pacing algorithm just received the CE Mark in Europe. AdaptivCRT within Viva and Brava CRT-D’s was developed to reduce the number of pacing signals delivered to the heart while improving the response by taking into account the patient’s cardiac status over time.
The new algorithm driving the Viva and Brava is currently only approved for investigational use by the FDA and Medtronic has filed a PMA (premarket approval) submission seeking clearance for the technology in the U.S.
More about the technology within the new implants from the announcement:
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 optimized using time-consuming, echocardiography-guided AV programming, and experienced an average response rate of 66 percent.
Until now, attempts to improve patients’ response rates with device timing optimization (echocardiographic-based or device-based) have resulted in modest incremental clinical benefits. These optimization 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 optimizes simply and automatically as the algorithm continually adjusts to the patient’s dynamic intrinsic conduction, and enables more natural contractions as it synchronizes ventricular contraction. 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.
The Viva/Brava CRT devices are designed to promote patient comfort by reducing skin pressure by 30 percent compared to most other CRT devices.1 The design also provides additional longevity for the devices. Other features of the new CRT portfolio include:
- Ensure CRT suite with Cardiosync® In-Office Optimization, which works to maximize CRT treatment, even during atrial fibrillation.
- SmartShock™ Technology, which includes six Medtronic-exclusive algorithms that recognize life-threatening arrhythmias but deliver therapeutic shocks only when appropriate.
- OptiVol® 2.0 Fluid Status Monitoring, which measures changes in fluid build-up in heart failure patients to identify patients at risk of worsening heart failure.