FDA Approves BIOTRONIK’s Record Smallest 3T Tachycardia Devices

Cardiac devices, courtesy of BIOTRONIK.

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BIOTRONIK has announced the recent U.S. Food and Drug Administration (FDA) approval of their Acticor and Rivacor device lines for the treatment of tachycardia. The devices, including the Rivacor VR-T, Rivacor HF-T QP, Rivacor DR-T, Acticor DX, Acticor CRT-DX, and Acticor CRT-DX Bipolar, are intended for patients with severe heart arrythmias.

These systems intend to provide both therapeutic and diagnostic capabilities while maintaining a compact shape and long battery life. BIOTRONIK boasts that the shape is not only small, but ergonomically favorable with rounded edges and an elliptical shape that lessens skin pressure and helps to lower skin erosion risk while maintaining patient comfort. As such, the Acticor and Rivacor are currently the smallest and slimmest 3 Tesla MR-conditional cardiac rhythm management devices in the industry.

The devices also possess extended longevity, with the battery life varying from nine to fifteen years across the two families of devices. These lengthened battery lives eventually lead to fewer device replacements and therefore fewer procedures required, minimizing costs and risk of patient complications. The product ranges also provide extended device warranties.

“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features,” said Dr. Larry A. Chinitz, a cardiac electrophysiologist in New York City. “We are often forced to choose between important features, which could compromise optimal patient care. 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.”

Market research published by iData Research shows that devices such as the Acticor and Rivacor are gradually becoming more popular treatment options in the United States. The annual growth rate of ICD/CRT devices has nearly quadrupled since 2013, mainly driven by a continually aging population and the emergence of new technologies, such as the overall miniaturization of cardiac devices. Additionally, smarter device software has had a positive effect on the market as new devices have diagnostic capabilities as well as therapeutic.

Both the Acticor and Rivacor lines are compatible with BIOTRONIK Home Monitoring, which has helped create a general 60 percent reduction in all-cause heart failure mortality and 36 percent reduction in hospitalization.


For Further Information

More on the cardiac rhythm management (CRM) market in the US can be found in a series of reports published by iData entitled the US Market Report Suite for Cardiac Rhythm Management.


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