Biotronik Addresses US CRM Market With Its Rivacor And Acticor Lines
The company recently launched six new implantable high-voltage cardiac rhythm management devices with the thin elliptical BIOshape to minimize the risk of skin erosion around the device pocket. Rivacor and Acticor also feature Biotronik's DX leadless atrial diagnostic technology, and MRI AutoDetect which automatically switches the device to a MR-safe mode when it enters a magnetic resonance imaging environment.
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The company says Biomonitor III documents suspected arrhythmias or unexplained syncope in patients who have experienced cardiac arrhythmias or who are at risk for cardiac arrhythmias.
Results of the SENSE trial showed Biotronik’s DX system, which is available in both ICD and CRT-D devices, can detect atrial high-rate episodes as effectively as dual-chamber ICDs and better than single-chamber ICDs even though it does not have an atrial sensing lead.
Approvals reported from eight different territories, including three new PMAs and eight PMA supplements, allowed the number of approvals in February to keep pace with January’s count.