FDA News

FDA approves devices for cardiac rhythm management

Biotronik announced the FDA approved six of its devices designed to treat patients with cardiac arrhythmias.

The devices (Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX) are smaller and slimmer than previous cardiac rhythm management devices but have a number of diagnostic and therapeutic capabilities, according to a press release from the company.

Features include rounded edges to reduce skin pressure and erosion, greater longevity than previous devices and cardiac resynchronization therapy programming that automatically adjusts to changes in conditions of patients with HF, the company stated in the release.

Larry A. Chinitz

“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features,” Larry A. Chinitz, MD, electrophysiologist and director of the Heart Rhythm Center at NYU Langone Health, said in the release. “We are often forced to choose between important features, which could compromise optimal patient care. The approval of Acticor and Rivacor offers choices to avoid this compromise. Intelligent software built into these devices enables us to assess disease states and respond accordingly with flexibility and customization. These devices offer sophisticated programming and automation as well as longer battery life, smaller size and greater MRI access (3 T). Our hope is that this will be a significant advance in device therapy and empower us to improve patient care while reducing long-term risk.”

Disclosure: Chinitz reports he received compensation for services from Abbott, Biosense Webster, Biotronik, Medtronic and Pfizer and fellowship support from Biotronik, Boston Scientific and Medtronic.

Biotronik announced the FDA approved six of its devices designed to treat patients with cardiac arrhythmias.

The devices (Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX) are smaller and slimmer than previous cardiac rhythm management devices but have a number of diagnostic and therapeutic capabilities, according to a press release from the company.

Features include rounded edges to reduce skin pressure and erosion, greater longevity than previous devices and cardiac resynchronization therapy programming that automatically adjusts to changes in conditions of patients with HF, the company stated in the release.

Larry A. Chinitz

“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features,” Larry A. Chinitz, MD, electrophysiologist and director of the Heart Rhythm Center at NYU Langone Health, said in the release. “We are often forced to choose between important features, which could compromise optimal patient care. The approval of Acticor and Rivacor offers choices to avoid this compromise. Intelligent software built into these devices enables us to assess disease states and respond accordingly with flexibility and customization. These devices offer sophisticated programming and automation as well as longer battery life, smaller size and greater MRI access (3 T). Our hope is that this will be a significant advance in device therapy and empower us to improve patient care while reducing long-term risk.”

Disclosure: Chinitz reports he received compensation for services from Abbott, Biosense Webster, Biotronik, Medtronic and Pfizer and fellowship support from Biotronik, Boston Scientific and Medtronic.