First 34 US patients implanted with Evia HF-T pacemaker after FDA approval


Biotronik has announced that 34 patients have been implanted with the Evia HF-T triple-chamber cardiac resynchronisation therapy (CRT) pacemaker in the days following device approval by the Food and Drug Administration (FDA).

Evia HF-T offers Biotronik’s Closed Loop Stimulation (CLS) technology. The company states that this is “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, University of Toledo, Ohio, USA. “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.”

Hospitals participating in the initial implantations are:

  • University of Massachusetts Medical Center, Worchester, Massachusetts;
  • New York Presbyterian Hospital, Cornell, New York, New York;
  • Walter Reed Army Medical Center, Bethesda, Maryland;
  • Spartanburg Regional Hospital, Spartanburg, North Carolina;
  • North Mississippi Medical Center, Tupelo, Mississippi;
  • Archbishop Bergan Mercy Medical Center, Omaha, Nebraska;
  • University of Utah Medical Center, Salt Lake City, Utah; and
  • Good Samaritan Hospital, Los Angeles, California