Biotronik has bagged US FDA approval for its high-voltage cardiac rhythm management (CRM) devices – Acticor and Rivacor range of devices for treating heart arrhythmia or cardiac arrhythmias.
The six new tachycardia solutions approved by the FDA are Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX and Acticor CRT-DX Bipolar. Biotronik is looking to launch the Acticor and Rivacor CRM devices in the US in April 2019.
The Acticor and Rivacor systems are designed to enable more diagnostic and therapeutic capabilities in smaller devices with extended battery longevity, said Biotronik.
The German biomedical technology company further said that the FDA approved CRM devices will give more comprehensive therapy options to physicians in treating heart patients with different disease states and comorbidities.
According to Biotronik, Acticor and Rivacor devices are currently the smallest and slimmest 3 Tesla MR-conditional CRM devices on the market. The two CRM systems, which feature a smooth elliptical BIOshape, can increase patient comfort by reducing skin pressure and lowering the chances of skin erosion as they are ultraslim with rounded edges.
Biotronik said that the extended longevity of the six CRM devices means lesser device replacements, less number of procedures for patients, thereby lowering risks, complications, and costs.
The Acticor family of CRM devices, which features the German company’s DX technology, offers atrial diagnostics without an atrial lead. The CRM devices in this range are capable of detecting silent atrial fibrillation that is helpful to prevent stroke. Acticor also enhances diagnostic accuracy for improved clinical decision-making while enabling dual-chamber supraventricular tachycardia (SVT) discrimination to remove the need for unnecessary shocks.
Rivacor HF-T QP is said to give more flexibility than any other existing CRT device systems, claimed Biotronik. Its intelligent CRT AutoAdapt programming adjusts to changes in patient conditions automatically, thereby allowing real-time responsive care while saving the time of both physicians and hospitals.
Ryan Walters – President of Biotronik 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.”