BIOTRONIK US Launches Smallest MR Conditional Quadripolar Cardiac Resynchronization Therapy Pacemaker

Edora HF-T QP Completes BIOTRONIK's ProMRI Portfolio

Lake Oswego, OR /PRNewswire/ - BIOTRONIK today 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,1 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 failure2 and a 36 percent reduction in hospitalization for worsening heart failure.3

"Patient care is a constant journey. It doesn't end when the patient leaves my office or recovers from a procedure. As healthcare providers, we must think beyond today and help ensure patients are appropriately cared for throughout their lifetime," said Dr. Roderick Tung, a cardiac electrophysiologist in Chicago. "MR conditional CRT-Ps that can be programmed to automatically switch to MRI mode when they enter the MRI environment are another significant step in delivering the best possible care throughout the patient journey. This technology eliminates an office visit for patients and decreases administrative burden for providers. The impact is significant, especially in institutions that perform cardiac MRI for advanced ventricular care."

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.

"With the launch of Edora HF-T QP, BIOTRONIK offers a full suite of ProMRI products ensuring physicians can always choose MRI conditional devices for their patients," said Marlou Janssen, President of BIOTRONIK, Inc. "Our devices are the only FDA-approved CRM solutions that provide automatic detection of an MRI environment, physiologic rate adaptation and automatic daily remote monitoring. These are differentiators that contribute to personalized and preventive care that impacts long-term health outcomes."

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.4

References
¹ 9 years, 8 months: DDD(R) @ 2.5 V, 0.4 ms, 60 ppm, A: 10% pacing, RV/LV: 100% pacing, 500 Ω, RF-Telemetry: OFF, Home Monitoring: OFF.
² Hindricks G et al. The Lancet. 2014, 384(9943).
³ Hindricks G et al. European Heart Journal. 2017, May 10. doi: https://doi.org/10.1093/eurheartj/ehx015
⁴ Whellan DJ et al. J Am Coll Cardiol. 2010, 55(17).

About BIOTRONIK
A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris**, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar-18, the world's first 4F compatible stent for treating long lesions; Orsiro*, the ultrathin 60 micron drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI technology.

* Not currently available in the United States.
** CAUTION – Investigational device. Limited by United States law to investigational use.

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