US FDA approves Biotronik’s Intica CRT-DX therapy implantable cardioverter defibrillator systems


The US Food and Drug Administration (FDA) has approved Biotronik’s Intica DX and Intica cardiac resynchronisation therapy (CRT)-DX implantable cardioverter defibrillator (ICD) systems, which are now available for sale.

DX technology is designed to eliminate the need for an atrial lead while still providing physicians with critical diagnostic information based on a true atrial signal.

Biotronik launched DX technology in 2013 with a focus on decreasing the rate of complication. The technology minimises hardware and provides diagnostics that are designed to allow physicians to better monitor, manage and prevent cardiac events. Intica CRT-DX is the first cardiac rhythm management device for the treatment of heart failure patients that delivers atrial diagnostics without an atrial lead.

“When treating heart failure patients, we are often managing several comorbidities that can increase the likelihood of complications and risk when implanting a CRT-D and in the years that follow,” says Larry Chinitz, a cardiac electrophysiologist in New York City. “Balancing risk and therapeutic needs has historically been a challenge… Now there is an ICD for heart failure patients that minimises hardware and risk while providing optimal diagnostics to help patients feel better and stay out of the hospital.”

Intica CRT-DX also includes Biotronik’s recently FDA-approved MultiPole Pacing (MPP) technology. MPP is designed to enable the left ventricle (LV) to be paced twice per cardiac cycle—sequentially or simultaneously—allowing for even greater customisation of heart failure therapy.


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