BIOTRONIK Announces FDA Approval And First U.S. Implants Of Philos II DR-T Pacemaker

BIOTRONIK, Inc. today announced the U.S. Food and Drug Administration (FDA) approval and first implants of a second-generation Home Monitoring(R) product: the Philos II DR-T pacemaker. The device is part of a state-of-the-art system that incorporates Home Monitoring early detection technology, Active Capture Control (ACC), Wideband IEGM, Auto-Initialization, Rate Fading, and Stored Follow-up Records.

"The FDA approval of our Philos II pacemaker family represents another significant advancement of our leading-edge technology," said Jake Langer, President of BIOTRONIK, Inc. "The combination of our exclusive Home Monitoring early detection technology and Active Capture Control algorithm will surely revolutionize today's follow-up procedure and further benefit our patients."

The first U.S. implants of Philos II DR-T were performed at Missouri Baptist Medical Center in St. Louis, Mo., by Dr. Stephen J. Pieper of the Heart Health Center, and at Palmetto Health Baptist in Columbia, S.C., by Dr. W.W. Stuck of the Columbia Heart Clinic.

Both electrophysiologists were very impressed by the enhancements in Home Monitoring early detection technology, most notably by the feature that allows physicians to monitor ventricular threshold trends from the convenience of their computers. "Home Monitoring early detection technology is certainly the way of the future," said Dr. Pieper. "It has the ability to quickly notify my office when arrhythmias occur. This offers a potential advantage in getting early treatment for some patients."