Biotronik said yesterday it won FDA approval for its Acticor and Rivacor high-voltage cardiac rhythm management devices intended for treating patients with cardiac arrhythmias.
The clearance covers the Berlin, Germany based company’s Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX devices.
“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. 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 Tesla). 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,” cardiac electrophysiologist Dr. Larry Chinitz said in a prepared statement.
Biotronik said that its Acticor and Rivacor systems include more diagnostic and therapeutic capabilities in a smaller form factor with extended battery longevity, and added that both devices have 3 Tesla MR-conditional labeling. Both systems are also equipped with the company’s home monitoring technology which Biotronik claims reduces all-cause mortality due to heart failure by 60%.
“Simplifying care through exceptional diagnostics and automated therapy is another example of how Biotronik continues to help physicians provide unmatched patient care. The Acticor and Rivacor device systems reflect Biotronik’s commitment to engineering solutions with profound positive impact for patients, physicians and health systems. We remain focused on bringing cardiac solutions to the US market that streamline processes and improve the ability to deliver care without compromise. There isn’t anything on the market that compares to Acticor and Rivacor,” prez Ryan Walters said in a press release.