BIOTRONIK Launches First and Only 42 Joule Ultra-High Energy ICD for Heart Failure Patients

Inventra ICD System Designed and Developed for Patients with Higher Defibrillation Thresholds

BIOTRONIK today announced the launch of Inventra HF-T, the first and only implantable cardioverter defibrillator (ICD) available in the United States that delivers an "ultra-high" energy with 42 joules (J) on the first shock. Inventra is an ICD designed for heart failure patients known as a cardiac resynchronization therapy defibrillator (CRT-D).

For many patients suffering from tachycardia (fast arrhythmias), an ICD is necessary to convert dangerous arrhythmias to a normal heart rhythm. ICDs provide life-saving shocks to the heart as needed. Patient anatomy and health conditions impact the heart's response to shock therapy. To save lives, it is critical for an ICD to deliver an effectively powerful shock as soon as possible.

"For an increasing number of patients – specifically those with larger cardiac anatomy and lower ejection fraction – a shock that is higher than the standard 36-37 J may be needed to convert irregular arrhythmia," said Dr. Mark Mascarenhas, electrophysiologist at Jersey Shore University Medical Center in Neptune, New Jersey. "The sooner an effective shock can be delivered, the likelihood of survival increases for these patients. For such patients, a CRT-D that delivers ultra-high energy on the first shock has a higher chance of converting the irregular arrhythmia. With the availability of Inventra HF-T, more heart failure patients will be able to receive 42 J energy delivered upon the first shock and, hence, receive life-saving therapy."

BIOTRONIK's Inventra line of ICDs currently includes Inventra HF-T and Inventra DX. BIOTRONIK's DX system offers dual-chamber diagnostics with one specialized defibrillator lead, benefiting patients with minimized risk and expense.

"We invest significantly in research and development focused on advancements that improve patient lives and reduce risks, for the patient and the provider," said Marlou Janssen, President, BIOTRONIK, Inc. "Within the industry, BIOTRONIK stands out for its commitment to the principle of vertical integration. This means we design, develop and manufacture all critical components in house. The Inventra HF-T QP is the latest example of our dedication to producing devices of the highest quality and safety, as it is uniquely able to provide 42 J of energy at first shock without compromising battery longevity. I am proud that for the first time, heart failure ICD patients in the US can receive ultra-high energy therapy when needed."

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^**, 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.

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

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SOURCE BIOTRONIK