BIOTRONIK has received European regulatory approval for its Estella and Effecta lines of pacemakers, adding eight new bradycardia devices to the market.
The following is from the press statement issued by the company:
Estella dual- and single-chamber devices incorporate the company’s … BIOTRONIK Home Monitoring® system. Furthermore, with the advanced Vp Suppression® algorithm, the Estella pacemaker series significantly minimizes ventricular pacing. Chronic ventricular pacing is associated with an increased risk of hospitalization for heart failure and atrial fibrillation (AF). Vp Suppression switches to ADI(R) mode when intrinsic rhythm is present and operates in DDD(R) mode when intrinsic rhythm is absent. The switching criteria are physician-defined to allow individualized patient therapy. Finally, all models have ProMRI® technology and therefore can be safely used during MRI procedures under specific scanning conditions and when connected with BIOTRONIK ProMRI® leads.
The BIOTRONIK Effecta pacemaker series features optimized energy efficiency – a 50 % reduction of the electrical current consumption within its circuitry and an extension of the pacemaker longevity to more than 10 years. Effecta also includes the new IRSplus, which promotes the patient’s own intrinsic rhythm and also minimizes unnecessary ventricular pacing. Finally, the Effecta series offers enhanced safety with its automaticity, such as Atrial and Ventricular Capture Control and Auto Lead Check. The former ensures automatic adaptation of the output setting to changes in the atrial and ventricular pacing thresholds. Beat-by-beat ventricular backup pulses ensure no single beat is skipped. With the latter, lead integrity is automatically and continuously checked by measuring the lead impedance. These measurements do not require additional pacing and are done independently from pacing or sensing phases.
Press release: BIOTRONIK expands range of state-of-the-art pacing therapies with the European approval of the new Estella and Effecta pacemaker series …