BIOTRONIK Cardiac Resynchronization Defibrillator Devices Bring Closed Loop Stimulation Sensor to US Heart Failure Patients

LAKE OSWEGO, Oregon, May 5, 2015 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced today that a unique physiologic sensor is now available in the latest family of cardiac resynchronization therapy defibrillator (CRT-D) devices. Closed Loop Stimulation (CLS) is the only cardiac sensor capable of appropriately adapting heart rate in response to physiologic demands independent of body movements or respiratory rate.

Chronotropic incompetence – the inability of the heart to increase its rate to keep up with increased activity or demand ‑ is common in many heart failure patients. When programmed in a BIOTRONIK device, CLS provides appropriate rate response, similar to patients with healthy sinus nodes¹.

Most other CRT-D devices use accelerometers, which are mechanisms that sense physical activity and require patients to be in motion before increasing their heart rate. Yet, patients need appropriate rate response regardless of whether they are actively moving or completely stationary. CLS more closely mimics the human nervous system, responding to patients’ metabolic changes. It can sense and respond to acute mental stress, adjusting the heart rate without relying on motion. CLS, available in BIOTRONIK pacemakers since 2003, has been proven to be more responsive in activities of daily living than accelerometers².

“I've treated many patients with BIOTRONIK’s pacemakers equipped with CLS and have had excellent results,” said Dr. Chad E. Bonhomme, cardiac electrophysiologist with Community Health Network in Indianapolis, Indiana. “CLS in ICDs offers a new and exciting option to more closely mimic
normal physiology.

"In addition to rate adaptation, I look forward to seeing the potential benefits of increased exercise tolerance, improved heart variability and diminished orthostatic symptoms," continued Dr. Bonhomme. The latest BIOTRONIK Itrevia ICD and CRT-D series³ includes other advanced atrial therapies: morphology discrimination, Vp Suppression^®, atrial capture control, improved ATP optimization and LV pacing vectors. Combined, they create more therapeutic options to deliver effective therapy while reducing painful shocks. All devices include BIOTRONIK Home Monitoring^®, the first remote monitoring system and the only system with automatic daily transmission, which has been shown to reduce all-cause mortality by over 50 percent⁴.

“CLS is the only FDA-approved sensor to respond to acute mental stress on a beat-to-beat basis,” said Marlou Janssen, President, BIOTRONIK, Inc. “We are very pleased to make this unique technology available for heart failure patients. CLS is another BIOTRONIK core technology that works to improve the quality of patients’ lives, allowing them to experience a wider range of physiologic responses than with other CRM devices.”

1. ^{Malinowski K. PACE. 1998, 21(11): 2209–2213.}
2. ^{Abi-Samra F.M. et al. Europace. 2013, 15(6):849-56}
3. ^{Manufactured by BIOTRONIK SE & CO. KG}
4. ^{Hindricks G et al. The Lancet. 2014, 384(9943).}