BIOTRONIK Announces FDA Approval of MultiPole Pacing with ProMRI: 360° Solutions for Patients with Heart Failure

Comprehensive Solution Exemplifies BIOTRONIK's Commitment to Patient Care

LAKE OSWEGO, OR -- BIOTRONIK today announced FDA approval of the company's MultiPole Pacing (MPP) technology, providing physicians with additional treatment options for heart failure patients who have been non-responsive to cardiac resynchronization therapy (CRT).¹ MPP will be available on new BIOTRONIK CRT defibrillator (CRT-D) systems for patients with heart failure.

Nearly 40 percent of heart failure patients are initially non-responsive to CRT.² BIOTRONIK's innovative MPP technology addresses this challenge by enabling the left ventricle to be paced twice per cardiac cycle. Uniquely, these paces can be either sequential or simultaneous, allowing for greater customization of therapy to meet specific patient needs. BIOTRONIK CRT-D systems include MPP and feature ProMRI^® technology, providing patients with access to critical diagnostic imaging scans as needed. These devices are also equipped with MRI AutoDetect, a dedicated sensor that detects the MRI environment, converts the patient's device to MRI mode, and then automatically returns to its permanent program when the scan is complete.

BIOTRONIK’s innovative MPP technology allows for greater customization of therapy to meet specific heart failure patient needs.

With the availability of MPP, BIOTRONIK now offers the most comprehensive MR conditional CRT portfolio available today to ensure physicians have access to the best possible cardiac rhythm management solution.

"MultiPole Pacing is an important technology that allows physicians to tailor cardiac resynchronization therapy to each patient," said Dr. Gery Tomassoni, Baptist Health, Lexington, Kentucky. "Heart failure is a complex condition and physicians are routinely challenged to find the ideal treatment for unique disease presentations. Adding MPP technology to other key BIOTRONIK features creates more options for physicians to meet evolving patient needs."

"When we develop technologies and evolve our devices, we think first and foremost about patients. Patients deserve the best care possible and innovation that truly enhances everyday life," said Marlou Janssen, President of BIOTRONIK, Inc. "Patients with heart failure are the most complex to treat, and they often have additional comorbidities that are likely to change and worsen over time. BIOTRONIK rises to this challenge by continuing to innovate, and offering impactful, customizable solutions to physicians that meet the ever-changing landscape of patients' needs."

BIOTRONIK's 360^o CRT technologies are designed to better equip physicians to meet the therapy needs of heart failure patients. These technologies include:

MultiPole Pacing – enables left ventricle to be paced sequentially or simultaneously
MRI AutoDetect – shortens window of reduced therapy and eliminates the need for post-MRI reprogramming
Closed Loop Stimulation – equips the device to respond appropriately to physiologic demands and acute mental stress
Ultra-High Energy CRT defibrillator – provides up to 42J of energy to meet patient needs on first and every shock
CRT-DX system – allows full CRT-D therapy with only two leads
The thinnest leads approved for use in MR conditional CRT systems, including Sentus ProMRI QP, also launched today.
BIOTRONIK Home Monitoring^® – automatically transmits device data daily; proven to reduce mortality in patients with heart failure by 50%³

Heart Rhythm attendees are encouraged to visit BIOTRONIK's booth (#820) to learn more about MPP and other 360^o CRT solutions.

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 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.

For more information, visit: www.biotronikusa.com

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¹Outcomes from use of BIOTRONIK MultiPole Pacing feature may be different than results obtained during St. Jude Medical MultiPoint Pacing (MPP) IDE study of their similar feature. The clinical effectiveness of this feature has not been established. BIOTRONIK is conducting an FDA-required post approval study to demonstrate that the MultiPole Pacing feature is effective by converting a percentage of CRT non-responders to responders.
²Mullens W et al. JACC. 2009, 53 (9).
³Hindricks G, et al. The Lancet. 2014, 384 (9943).

SOURCE BIOTRONIK