Healthcare Industry News:  BIOTRONIK 

Devices Cardiology Regulatory

 News Release - December 1, 2010

BIOTRONIK Expands Range of State-of-the-Art Pacing Therapies with the European Approval of the New Estella and Effecta Pacemaker Series

BERLIN--(Healthcare Sales & Marketing Network)-- BIOTRONIK SE Co. & KG, a leading manufacturer of implantable cardiac devices, has announced the further expansion of their comprehensive portfolio of pacing therapies with more solutions that serve a broad range of therapy needs for advanced patient management.

The eight newly released models comprising the Estella and Effecta pacemaker series, in combination with the four currently available models of the premium Evia series, represent one of the most comprehensive bradycardia portfolios on the market today.

All three pacemaker series - Evia, Estella and Effecta - are built on BIOTRONIK’s state-of-the-art unified platform technology, which enables the integration of key performance features across all lines.

Estella dual- and single-chamber devices incorporate the company’s pioneering 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)1,2. 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.

“Hundreds of thousands of patients with cardiac pacing devices are indicated for MRI scans at some point after their implantations; however, previous devices were not compatible with this type of diagnostic procedure,” commented Marlou Janssen, Global Vice President of Marketing and Sales. “Never before has another company been able to offer such a broad range of pacemaker systems that give patients safe access to MRI scanning procedures. The Estella series, in combination with the currently available premium Evia series, is setting new standards with its breadth of therapy options.”

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.

Within the time span of one year, BIOTRONIK has launched a completely new high quality pacing portfolio, bringing physicians and patients the world’s most comprehensive offering of solutions for the advanced management of patients with bradycardia.


As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 5,600 employees. Known for having its fingers on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face and provides the best solutions for all phases of patient care, ranging from diagnosis and treatment to patient management. Quality, innovation and clinical excellence define BIOTRONIK and its growing success - and deliver confidence and peace of mind to physicians and their patients worldwide.

More information:

1 Sweeney M., et al; Adverse Effect of Ventricular Pacing on Heart Failure and Atrial Fibrillation Among Patients with Normal Baseline QRS Duration in a Clinical Trial of Pacemaker Therapy for Sinus Node Dysfunction; Circulation (2003); 107: 2932 – 7.

2 Sweeney M., et al; Minimizing Ventricular Pacing to Reduce Atrial Fibrillation in Sinus Node Disease; N Engl J Med (2006); 113: 2082 – 8.


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