Biotronik’s tachycardia devices get US FDA clearance

May 8, 2019 0 By FM

Acticor and Rivacor high-voltage cardiac rhythm management (CRM) devices for treatment of patients with cardiac arrhythmias secured approval from US FDA, Biotronik said.

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 Acticor and Rivacor systems are designed to incorporate more diagnostic and therapeutic capabilities in smaller devices with extended battery longevity.

This provides physicians with more comprehensive therapy options when treating cardiac patients with varying disease states and comorbidities. With a smooth, elliptical BIOshape, Acticor and Rivacor devices are the smallest and slimmest 3 Tesla (3T) MR-conditional CRM devices on the market.

The slim devices have rounded edges that lessen skin pressure and help to lower the risk of skin erosion while increasing patient comfort. Extended longevity—nearly 15 years for VR-T, 13.5 years for DR-T, 14 years for DX and nine years for CRT—can lead to fewer device replacements, fewer procedures for patients reducing risks, complications and costs.

The Acticor devices offer DX technology, which provides atrial diagnostics without an atrial lead. DX systems can detect silent atrial fibrillation for stroke prevention, enhance diagnostic accuracy for better clinical decision-making and allow for dual-chamber supraventricular tachycardia (SVT) discrimination to prevent unnecessary shocks. By reducing the number of leads in the device system, DX technology also enables faster procedure times, lowers cost and reduces complications.

This intelligent CRT AutoAdapt programming automatically adjusts to changes in patient conditions, enabling real-time responsive care while saving time for physicians and hospitals.