Pacemakers Respond To Mental Stress

Lake Oswego, OR - BIOTRONIK, Inc. announced that it has received FDA approval to market its Protos CLS family of pacemakers as responding to physiologic demands instigated by exercise and acute mental stress. Proprietary technology embedded in these pacemakers, called Closed Loop Stimulation, integrates with the natural control centers of the heart to provide a physiologic and appropriate heart rate.

Historically, pacemakers have only been shown to fluctuate heart rates in response to aerobic exercise, such as walking on a treadmill. The fact that the Protos CLS family of pacemakers responds to exercise and non-exercise metabolic demands is a significant step forward in pacemaker design. These pacemakers can now provide appropriate heart rates, resulting in perfusion of oxygen to the body in a much more physiologic manner, mimicking a healthy heart. Because pacemaker patients cannot increase their heart rate on their own, their pacemaker becomes an essential mechanism for leading a healthy and productive life. Without this new CLS technology, patients may be deprived of essential blood flow when they are conducting non-exercise activities throughout the day.

Healthy patients have hearts that respond to multiple stimuli, such as watching a close championship game, engaging in a heated debate, or getting surprised at a party. These situations engage the autonomic nervous system, which drives a faster heart rate. The body has been designed to expect these higher heart rates, and there is evidence to suggest that increased blood flow helps healthy individuals to be more mentally attuned and have quicker responses.

BIOTRONIK conducted the Protos Emotional Response Study (ER Study) to prove its technology. Patients were subjected to mental agitation tests while their heart rates were continually monitored. The special CLS technology was turned on for half of the test and turned off for the other half. Patients were kept in a controlled environment so that they could only experience higher heart rates from acute mental stress. The results of the study showed a significant difference between a CLS-driven heart rate and a non-CLS-driven heart rate.

"Rate-adaptive pacing has become the standard of care for patients with slow heart rates," states Dr. Suresh Neelagaru, principle investigator for the ER Study. "We have always known that the existing technology has limitations, but it was better than nothing. Now, with CLS, we can finally implant devices that restore autonomic control to the heart. This is a clinically significant breakthrough. My patients are seeing appreciable improvements in their quality of life and increased energy levels. It is really quite clear what a difference this technology can make."

SOURCE: BIOTRONIK