BIOTRONIK Receives FDA Approval for Sentus ProMRI Quadripolar Left Ventricular Lead

LAKE OSWEGO, Oregon, May 8, 2017 /PRNewswire/ -- BIOTRONIK today announced FDA approval and the launch of Sentus ProMRI^®, the thinnest quadripolar left ventricular lead available in the United States. This introduction completes BIOTRONIK's second-generation ProMRI lead portfolio, which also includes Solia ProMRI and Plexa ProMRI.

Sentus ProMRI is approved for use with heart failure devices based on data collected during the QP ExCELs study. The study, which included 53 sites in the United States, demonstrated Sentus ProMRI QP's best in class performance. Key data points include:

• 97.1 percent complication-free rate at six months
• 1.43 percent lead dislodgement rate
• 93.4 percent of subjects achieved permanent pacing vector pacing threshold lower than 2.5 V at three months

As more patients are living longer with cardiac conditions, BIOTRONIK continues to invest in research and development to bring solutions to market that improve quality of life for patients. Sentus ProMRI is a quadripolar coronary sinus left ventricular (LV) lead with an isodiametric design that marries co-radial wire insulation technology and polyurethane coating for maximum flexibility and reduced friction. The lead's four electrodes feature BIOTRONIK's proven fractal iridium coating to maximize performance.

"With the array of leads available today, every patient should be implanted with an MR conditional device," said Dr. Venkat R. Iyer, electrophysiologist at Bayview Physicians Group in Norfolk, Virginia. "Our patients deserve nothing less than the best possible care. With MR conditional solutions, we can help ensure this continues throughout the patient care journey."

Sentus ProMRI completes the ProMRI quadripolar system when used with BIOTRONIK's Inventra HF-T QP cardiac resynchronization therapy defibrillator (CRT-D), making it the only MR conditional heart failure solution available in the United States that delivers ultra-high energy (42J) therapy on the first and every shock. This system offers Closed Loop Stimulation (CLS)?BIOTRONIK's unique physiologic rate-adaptive algorithm that automatically optimizes to each patient's needs based on real-time metabolic demand. It also features BIOTRONIK Home Monitoring^®, which has shown a 50% reduction in mortality¹ in patients with heart failure, as proven in the IN-TIME study.

"After more than 50 years with zero lead recalls, we continue to invest in solutions that positively impact patient lives," said Marlou Janssen, President at BIOTRONIK, Inc. "By equipping physicians with the most impactful cardiovascular solutions to confidently treat patients, we reinforce BIOTRONIK's dedication to advancing innovation that matters to health systems, physicians and patients."

Reference
¹ Hindricks G, et al. The Lancet. 2014, 384 (9943).

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