Biomedical technology company Biotronik has launched the smallest MR-conditional tachycardia lead available in the U.S.
The Plexa ProMRI was approved by the U.S. Food and Drug Administration (FDA) on Feb. 1 for use with implantable cardioverter defibrillators (ICDs) and heart failure devices, according to an April 18 press release.
Biotronik’s U.S. headquarters are in Lake Oswego, Oregon, but its global headquarters are in Berlin, Germany.
"This is another advancement in efforts to further improve the performance and maneuverability of ICD leads," said Theofanie Mela, MD, an electrophysiologist at Massachusetts General Hospital and one of the first physicians in the US to implant Plexa, in a statement. "Patients who require ICDs are understandably concerned about reliability, and that underscores the need for durable ICD leads to choose from."
The device is also available in various DF4, Df-1 and DX configurations, which sets them apart from other devices like it.
"Biotronik is committed to continuously advancing the quality of our cardiovascular solutions for patients and physicians because excellence never rests," said Marlou Janssen, president of Biotronik, in a statement. "With a commitment to clinical research, we have championed reliable leads for more than 50 years. Biotronik invested nearly a decade of research and development to bring Plexa ProMRI to market and we'll continue these efforts to ensure Plexa ProMRI consistently surpasses expectations."