Biotronik, a Germany-based biomedical technology company, has secured approval from the US Food and Drug Administration (FDA) for its Acticor and Rivacor high-voltage cardiac rhythm management (CRM) devices for treatment of patients with cardiac arrhythmias.
Biotronik said the Acticor and Rivacor systems are designed to incorporate more diagnostic and therapeutic capabilities in smaller devices with extended battery longevity.
The six new tachycardia solutions include Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX.
The devices are expected to provide more comprehensive therapy options to the physicians while treating cardiac patients with varying disease states and comorbidities.
Acticor and Rivacor devices, which feature a smooth, elliptical BIOshape, are the smallest and slimmest 3 Tesla MR-conditional CRM devices on the market. The devices are ultraslim with rounded edges to reduce skin pressure and lower the risk of skin erosion while increasing patient comfort.
The company said that an extended longevity of nearly 15 years for the device VR-T, 13.5 years for DR-T, 14 years for DX and nine years for CRT, is provided to reduce the device replacements, procedures for patients, risks, complications and costs along with providing confidence for health systems to partner with the company.
Acticor family devices feature DX technology, which provides atrial diagnostics without an atrial lead and capable of detecting silent atrial fibrillation to prevent stroke, enhance diagnostic accuracy for better clinical decision-making and allow for dual-chamber supraventricular tachycardia (SVT) discrimination to prevent unnecessary shocks.
Biotronik president Ryan Walters said: “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.”
Biotronik said that the devices features MRI AutoDetect technology to automatically recognize when a patient enters an MRI environment and adjusts therapy for the duration of the scan. The technology simplifies hospital workflows and improves patient safety.