FDA approval for Edora HF-T QP, an MR conditional cardiac resynchronization therapy pacemaker with MRI AutoDetect technology. -Biotronik

Biotronik announced FDA approval and commercial availability of Edora HF-T QP, an MR conditional quadripolar (QP) cardiac resynchronization therapy pacemaker (CRT-P) with MRI AutoDetect technology. With a volume of 15 cc, Edora HF-T QP is the smallest MR conditional CRT-P available in the US with longevity of nearly 10 years, reducing the frequency of device replacements for heart failure patients.

Edora HF-T QP features MRI AutoDetect, Closed Loop Stimulation (CLS) and Biotronik Home Monitoring with automatic, daily transmission verification. Biotronik Home Monitoring is the only cardiac device remote monitoring system clinically proven to improve health outcomes in heart failure. In recent studies, Biotronik Home Monitoring was associated with a greater than 50 percent reduction in mortality due to heart failure and a 36 percent reduction in hospitalization for worsening heart failure.

Biotronik�s MRI AutoDetect technology is designed to improve patient safety by minimizing the time the device is in MRI mode and remedying logistical programming challenges for physicians and health systems. Once activated by a clinician, MRI AutoDetect automatically recognizes when a patient enters an MRI field and changes the device programming to MRI mode.

The Biotronik Home Monitoring system includes the Heart Failure Monitor� Online, a summary of nine long-term heart failure statistics including thoracic impedance. When combined with daily updates, this allows physicians to continuously monitor and evaluate patients� heart failure status. Equipped with comprehensive patient monitoring and easily accessible statistical trends, physicians can review individual patient data quicker, leading to early intervention and better outcomes..