Immediately following the U.S. Food and Drug Administration’s (FDA) approval, Biotronik began delivering the new Evia HF-T devices to medical centers across the United States to meet considerable demand for improved therapeutic options for patients. The first 34 patients received devices in the days following device approval by the FDA, with dozens more scheduled in the following weeks.
Hospitals participating in the initial implantations are located across the country, including:
- University of Massachusetts Medical Center, Worchester, Massachusetts;
- New York Presbyterian Hospital, Cornell, New York, N.Y.,
- Walter Reed Army Medical Center, Bethesda, Md.,
- Spartanburg Regional Hospital, Spartanburg, N.C.,
- North Mississippi Medical Center, Tupelo, Miss.,
- Archbishop Bergan Mercy Medical Center, Omaha, Neb.,
- University of Utah Medical Center, Salt Lake City, Utah, and
- Good Samaritan Hospital, Los Angeles, Calif.
Evia HF-T offers the company’s revolutionary Closed Loop Stimulation(CLS) technology, the only rate response algorithm that is FDA-approved to respond to exercise and acute mental stress on a beat-to-beat basis.
“For me, this device means my options for using CLS — a therapy that is both much needed and well documented in my clinical practice — are expanded to include patients with heart failure,” said Blair Grubb, M.D., from the University of Toledo, Ohio. “Patients in general can — and do — benefit from this unique physiologic rate-adaptive pacing mode, but patients with heart failure may derive unique benefit since adaptive algorithms dependent on physical activity alone may not respond as appropriately.”
“Electrophysiologists ranging from private practice to academic training centers agree that Biotronik’s Evia HF-T offers groundbreaking technology, which makes it an ideal option for patients with heart failure conditions,” said Rex Richmond, vice president of Marketing at Biotronik Inc. “This unique CRT pacemaker completes Biotronik’s quest to offer a full line of highly competitive products in the United States, Evia HF-T is the only CRT pacemaker to offer all the therapeutic benefits available in competing CRT pacemakers — plus unique technology, such as cellular home monitoring with no cost to the patient.”
He continued, “We’ve been listening to what physicians have been asking for and Evia HF-T is today’s example of a device that fulfills the needs of both patients and physicians, and there are more to come.”
“Biotronik is poised to deliver exactly what is needed at a time of rapid change and increased scrutiny in the world of medicine,” added Richmond. “Moving forward, we’ll continue to focus on why Biotronik is — and has been — the right choice, both now and in the future.”
Increased lung fluid levels can be one indicator of heart failure progression, and BIOTRONIK’s Evia HF-T devices contain the company’s proprietary TI feature, which measures thoracic impedance. The patient’s physician can use this information as additional insight to manage critically important aspects of patient care.
The Evia HF-T system also includes the company’s innovative Biotronik Home Monitoring technology, which automatically transmits a patient’s clinical and device status on a daily basis — making it readily available to the physician without the need for any patient interaction. Biotronik Home Monitoring is the industry’s only remote patient management system with FDA-approval for early detection of clinically relevant events. TI is one of nine potentially meaningful heart failure parameters transferred by Biotronik Home Monitoring. Several parameters allow for customizable alert settings.
For more information: www.biotronik.com