Biotronik gets FDA nod for 3T tachycardia devices

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.

Page 1 of 602
Next Page