First U.S. Patients for Biotronik’s Newly Approved Itrevia HF-T QP CRT-D Device

Cardiovascular medical technology company Biotronik, updates us about its Itrevia HF-T QP cardiac resynchronization defibrillator (CRT-D) devices which have now seen use in first U.S. patients following FDA approval.


Orthostatic hypotension occurs in 30-50 percent of elderly patients with disease or medication risk factors and is associated with falls, syncope and hospitalization.┬áDirectly addressing the issue, Biotronik’s Itrevia HF-T QP includes the unique Closed Loop Stimulation (CLS) algorithm, which is uniquely capable of appropriately adapting heart rate in response to physiological demands, independent of body movements or respiratory rate.

The company claims its algorithm provides a superior solution to the traditional accelerometer-based devices, citing the CLEAR study which shows a 75 percent reduction in the prevalence of orthostatic hypotension.

The difference stems from the fact that accelerometers sense physical activity and require patients to be in motion before increasing their heart rate. CLS claims to mimic the human nervous system more closely, responding to the patient’s metabolic changes and acute mental stress and adjusting the heart rate without relying on motion.

Itrevia HF-T QP was recently FDA approved for use with IS4 compatible left ventricular (LV) leads. The CRT-D device has a quadripolar header, which gives more LV pacing options to optimize the CRT therapy.

Physician comments

“This device meets standards of other devices in the market and then adds CLS,” said Dr. Alexander Mazur, MD, Clinical Associate Professor from the University of Iowa in Iowa City. “My patients with heart failure have greater risk of falling due to the incidence of orthostatic hypotension and it is beneficial to have the option of using CLS to treat them.”

Company comments

“The FDA has approved CLS as the only system to respond to acute mental stress and now this unique technology is available for more patients who can benefit from the expanded programming options of a quadripolar device,” said Marlou Janssen, President, Biotronik, Inc.”CLS and BIOTRONIK Home Monitoring are core technologies in our Biotronik pacemakers and ICDs because we know, and have clinical evidence, that these technologies can improve the quality of patients’ lives.”

Source: Biotronik

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