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FDA approval of MR conditional cardiac resynchronization

Iperia HF-T Completes BIOTRONIK's US Portfolio of MR Conditional Tachycardia Devices.

BIOTRONIK, a leader in cardio- and endovascular medical technology,
have received Food and Drug Administration (FDA) approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging (MRI) scans. Iperia devices also have remote monitoring with daily automatic transmission and closed loop stimulation (CLS) that adapts the heart rate in response to physiological demands.

More than five million Americans suffer from heart failure (HF). The condition occurs when the heart isn't able to pump enough blood and oxygen to the rest of the body. Patients, often elderly and living with significantly diminished quality of life, are at high risk for comorbidities, including diabetes, cardiac arrhythmias, depression, and falls that can lead to hospitalization.

"Heart failure patients are often struggling with other health conditions that require medical intervention," said Dr. Theofanie Mela, an electrophysiologist at Massachusetts General Hospital who participated in the testing of this device. "These patients need effective and efficient treatment. Access to MRI scans is a critical step to ensuring quality patient care extends beyond device implantation. This must become the standard of care."

Iperia HF-T was developed with BIOTRONIK's ProMRI, Home Monitoring, and CLS technology, creating an advanced cardiac resynchronization therapy defibrillator (CRT-D) designed to support each patient's unique healthcare journey. BIOTRONIK's MR conditional tachycardia devices ensure patients have access to 1.5T scans without an exclusion zone. Home Monitoring provides automatic daily transmission of data relating to arrhythmic events and heart failure statistics, which have been shown to reduce all-cause mortality by more than 50 percent. For heart failure patients, early detection of deterioration reduces patient mortality[1].

"The FDA approval of Iperia HF-T demonstrates the shift that is happening in cardiovascular patient care," said Marlou Janssen, President, BIOTRONIK, Inc. "BIOTRONIK now offers a comprehensive portfolio of MR conditional ICDs. We're driving the standard of care to new levels by providing physicians and hospitals with innovative, reliable, cardiac devices that ensure patients have access to imaging technology critical to diagnosing and treating future illness and injury. This is technology that is making a difference in patients' lives."

About ProMRI®
BIOTRONIK ProMRI technology enables patients with a pacemaker, implantable defibrillator, cardiac monitor, or cardiac resynchronization therapy defibrillator (CRT-D) or pacemaker (CRT-P) to undergo an MRI scan. BIOTRONIK has the broadest portfolio of cardiac devices approved for use in the MR environment on the market. For more details, please go to www.biotronik.com/promri.

About BIOTRONIK Home Monitoring
BIOTRONIK Home Monitoring can be programmed by a physician to transmit data automatically and on a daily basis, thereby rapidly detecting deterioration in a patient's clinical status. The occurrence of atrial or ventricular arrhythmias or specific trends in certain clinical parameters can often be the first sign of worsening heart failure leading to hospitalization or death. Early detection of these clinically relevant events, in particular asymptomatic atrial fibrillation, enables the physician to adapt patient therapy at a very early stage. Home Monitoring effectively supports the management of heart failure patients as well as lowering costs and streamlining workflow.

References
[1] Hindricks G et al. Lancet. 2014, 384 (9943).
* Investigational Device: Limited by U.S. law to investigational use.

BIOTRONIK in profile
One of the world's leading manufacturers of cardio- and endovascular medical devices, 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 BIOTRONIK Home Monitoring®; Pulsar*, the world's first 4 F compatible stent for treating long lesions; Orsiro*, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.

For further information, view website: www.biotronik.com or e-mail: manuela.schildwaechter@biotronik.com  Refer to page 274

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