Biomedical device company Biotronik has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Acticor and Rivacor families of high-voltage cardiac rhythm management devices.
Acticor and Rivacor are intended for the treatment of patients with cardiac arrhythmias and include six different devices: Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar, and Acticor CRT-DX.
The devices are designed to incorporate more diagnostic and therapeutic capabilities into a smaller design with longer battery life, giving physicians more options when treating cardiac patients with different disease states.
The devices are rated as MR-conditional for use in a 3-tesla MR environment and have an ultraslim design and rounded edges to reduce skin pressure and lower the risk of skin erosion.
