BIOTRONIK Announces Food and Drug Administration Approvable Status for Revolutionary Heart Failure Therapy System.

BOSTON -- Full Cardiac Resynchronization Therapy System combines superior performance and versatility with BIOTRONIK's pioneering Home Monitoring technology

BIOTRONIK today received Approvable status from the United States Food and Drug Administration for the Kronos LV-T Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Corox OTW Coronary Sinus lead. Kronos and Corox complete BIOTRONIK's pioneering Heart Failure Therapy System, which also includes the ScoutPro Lead Delivery System, Galeo guide wire family, and the BIOTRONIK Home Monitoring remote patient management system.

The BIOTRONIK Cardiac Resynchronization Therapy (CRT) system introduces two major new technologies to the U.S. heart failure physician and patient. The Kronos LV-T is an industry leading CRT defibrillator offering a wireless heart Failure Monitor for continuous tracking and monitoring of the status of heart failure patients. Six proven variables are automatically tracked and trended daily to give the Congestive Heart Failure (CHF) managing physician insight into the patient's improvement or even impending decompensation -- before they end up in the emergency room.

In addition to the Kronos LV-T, BIOTRONIK's Heart Failure Therapy system includes the Corox OTW coronary sinus lead. Corox sets a new performance standard with low acute and chronic thresholds averaging below 1 V. The Progressive Curve configuration of the Corox OTW means the lead coils distinctively at the tip, with a more relaxed curvature further from the apex, when the guide wire or stylet is removed. The primary advantage of this configuration is secure fixation in a wide range of vein diameters. The second key attribute is that the electrode is positioned against the wall of the vessel -- not floating in the center -- which leads to significantly lower acute and chronic LV thresholds than competitors' CS leads.

Through Home Monitoring, the Kronos automatically transmits intracardiac electrograms (IEGMs) via radiofrequency (RF) communications and allows the physician to view this vital patient information on a secure website at anytime, from anywhere. For heart failure patients, the six automated variables (mean heart rate, mean heart rate at rest, patient activity, VES per hour, percentage of CRT, and AF burden) allow the physician to follow their patients remotely and automatically for a higher level of patient care.

BIOTRONIK's U.S. headquarters are located near Portland, Oregon. Started in 1963, BIOTRONIK today ranks as one of the leading cardiac rhythm management (CRM) companies, conducting business in over 60 countries worldwide and providing a full range of innovative cardiovascular products of the highest quality and reliability. BIOTRONIK has pioneered many innovative technologies, including Closed Loop Stimulation(R) and Home Monitoring(R), which provides real-time early detection of arrhythmias and disease progression through proprietary wireless technology. BIOTRONIK's motto, "Technology Helping to Heal," is reflected in the company's primary guiding principle: helping patients by researching, developing, and marketing biomedical products to restore, secure, and enhance their quality of life.