Oregon-made heart device that prevents falls gets first human test

The first patients have been implanted with a new cardiovascular device made by Biotronik in Lake Oswego.

The device is called an Itrevia HF-T QP cardiac resynchronization defibrillator. What makes it unique is that it includes a special algorithm called CLS that’s capable of adapting heart rate in response to physiological demands, independent of body movements or respiratory rate.

The U.S. Food and Drug Administration recently approved the device for use with a specific lead. There are overall 90,000 cardiac resynchronization therapy defibrillators implanted in the U.S. each year.

While Biotronik has about 10 percent of the market for all its devices, the new innovation could help boost that share.

“This device meets standards of other devices in the market and then adds CLS,” said Dr. Alexander Mazur, clinical associate professor at the University of Iowa, said in a statement.

He said the device is beneficial for patients with heart failure have a greater risk of falling due to “orthostatic hypotension,” which occurs in 30 percent to 50 percent of elderly patients with disease or medication risk factors and is associated with falls.

One study showed a 75 percent reduction in the condition with the CLS device compared with the tradition accelerometer, which senses physical activity only.

Biotronik, based in Berlin, Germany, is one of the world’s largest producers of pacemakers and defibrillators. Its North American headquarters sits in Lake Oswego, where the majority of its devices are made.

Along with Micro Systems Engineering, which assembles the electronics inside the devices, it employs 500 people at the plant.

The new CLS device gives patients appropriate rate responses regardless of whether they are moving or sitting still. The new device mimics the human nervous system more closely, responding to a patient’s metabolic changes and mental stress.

CLS has been available in Biotronik pacemakers since 2003. It’s been shown to be more responsive to the activities of daily living than accelerometers, according to Biotronik.

The device can be used as a replacement for an older generation device already in someone’s body, along with new implants, said Rex Richmond, vice president of marketing and communications.

“We’re excited because relatively sick patients that need a response they can’t get through motion alone will feel a lot better. It will be a noticeable upgrade,” Richmond said.

Elizabeth Hayes
Staff Reporter
Portland Business Journal
Jul 21, 2015


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