FDA Approves Record-Smallest Cardiac Rhythm Management Device

The US Food and Drug Administration (FDA) has approved a pair of high-voltage cardiac rhythm management (CRM) devices for the treatment of patients with cardiac arrhythmias.

With the approval, the Acticor and Rivacor brands from BIOTRONIK become the smallest, slimmest 3 Tesla (3T) MR-conditional CRM devices on the US market. They include 6 tachycardia solutions: Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX.

The smaller device design emphasizes more capabilities and an extended battery life, and rounded edges that reduce skin pressure and allow for lowered skin erosion risk. Their intent is to reduce the rate of patient device replacements, risk-reduction procedures, complications, and overall care costs.

According to BIOTRONIK, the device longevity is 15 years for VR-T, 14 years for DX, 13.5 years for DR-T, and 9 years for CRT.

Larry A. Chinitz, MD, a cardiac electrophysiologist at New York University Langone Health, explained that determining optimized therapy for a patient requires an assessment and understanding of the best device system capable of managing diagnostics.

“We are often forced to choose between important features, which could compromise optimal patient care,” Chinitz said in a statement. “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.”

Chinitz expressed hope the approval leads to significant advances in cardiovascular device therapy, while enabling physicians to “improve patient care while reducing long-term risk."

The devices are equipped with BIOTRONIK Home Monitoring, which has been associated in clinical trials with a 60%-plus reduction in patient all-cause mortality due to heart failure, as well as a 36% reduction in hospitalization due to worsening heart failure.

Ryan Walters, BIOTRONIK president, added praise for the device’s emphasis on improved diagnostics and automated therapy.

“We remain focused on bringing cardiac solutions to the US market that streamline processes and improve the ability to deliver care without compromise,” he said. “There isn't anything on the market that compares to Acticor and Rivacor."