FDA approves BIOTRONIK's new Estella and Effecta pacemakers

BIOTRONIK, a leading manufacturer of implantable cardiac devices and pioneer of wireless remote monitoring technologies, today announced FDA approval of the new Estella and Effecta pacemakers, as well as advanced new features and technologies for the Evia pacemaker family.

The Evia family combines the industry's smallest wireless remote monitoring pacemakers with a decade of longevity. This advancement increases the intervals between necessary device replacement procedures, which could potentially reduce the risk associated with replacements—a risk demonstrated in the recently published REPLACE study.

BIOTRONIK understands that physicians need to be able to tailor therapies appropriately to a patient's specific condition. The Evia family significantly expands BIOTRONIK's spectrum of innovative treatment options to maximize intrinsic conduction, thus reducing unnecessary right ventricular pacing. Ventricular pace suppression, known as Vp Suppression, is a new, highly sophisticated algorithm that can promote innate conduction by enabling the pacemaker to stimulate the heart muscle only when appropriate.

Jake Langer, President of BIOTRONIK USA, stated, "With the Evia family, BIOTRONIK now offers 10 different pacemaker models in its new platform. All electronic components are manufactured and tested with full automation—a further demonstration of our longstanding commitment to engineering quality solutions designed to enhance patients' lives."

Evia also features BIOTRONIK's proprietary Closed Loop Stimulation (CLS), a unique pacing solution with a proven, physiological rate regulation algorithm that is the most advanced on the market. CLS is the only rate-response technology to receive FDA labeling as responding to physical and acute mental stress.

BIOTRONIK Home Monitoring^® is another key feature of the Evia series—and one that has set an industry-leading standard for daily transmission of automated tests of device and lead functions. In 2009, the FDA approved labeling for BIOTRONIK Home Monitoring^® as the industry's only remote patient monitoring system that can replace conventional device interrogation during follow-ups.