Biotronik receives FDA approval for new cardiac devices

18 March 2019 (Last Updated March 18th, 2019 10:14)

Biotronik has secured approval from the US Food and Drug Administration (FDA) for the use of its Acticor and Rivacor cardiac rhythm management (CRM) devices to treat heart arrhythmias.

Biotronik receives FDA approval for new cardiac devices
The benefits of a rounded shape will be tracked during the study. Credit: Biotronik.

Biotronik has secured approval from the US Food and Drug Administration (FDA) for the use of its Acticor and Rivacor cardiac rhythm management (CRM) devices to treat heart arrhythmias.

These small 3 Tesla (3T) magnetic resonance (MR) conditional CRM devices have rounded edges to reduce skin pressure and help lower the risk of skin erosion. Their long battery lives ensure fewer replacement surgeries and reduce costs.

Biotronik president Ryan Walters said: “The Acticor and Rivacor device systems reflect Biotronik’s commitment to engineering solutions with a 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.”

“We remain focused on bringing cardiac solutions to the US market that streamline processes.”

The Acticor collection leverages the company’s DX technology, which identifies silent atrial fibrillation without the need of an atrial lead. This prevents strokes and improves diagnostic accuracy.

The devices also enable dual-chamber supraventricular tachycardia (SVT) discrimination to prevent unnecessary shocks.

The Rivacor HF-T QP has flexible programming options, including 20 left ventricular (LV) pacing vectors and cardiac resynchronisation therapy (CRT) optimisation. This CRT AutoAdapt programming facilitates automatic adjustment to changes in patient conditions, allowing responsive care in real-time.

Both Acticor and Rivacor devices include Biotronik Home Monitoring, which is claimed to result in a 60% decrease of mortality due to heart failure and a 36% reduction in hospitalisation for worsening heart failure.

The devices detect when a patient enters a magnetic resonance imaging (MRI) machine and adjusts the therapy for the duration of the scan.

Biotronik plans to launch the Acticor and Rivacor systems in the US next month.