Two Biotronik ICD systems receive FDA approval

Two implantable cardioverter defibrillator (ICD) systems made by Biotronik were approved by the U.S. Food and Drug Administration (FDA), the company announced July 19.

The two systems, the Intica DX and the Intica cardiac resynchronization therapy (CRT)-DX, eliminate the need for an atrial lead, but provide physicians with the necessary diagnostic information based on atrial signals.

Biotronik introduced its DX technology in 2013 as it aimed to improve patient care and cut down on complications. The Intica CRT-DX is the first heart rhythm management tool that treats heart failure and gives 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," said Larry Chinitz, MD, a cardiac electrophysiologist in New York City, in a statement. "Balancing risk and therapeutic needs has historically been a challenge. CRT-DX changes this and creates a higher echelon of patient care. Now there is an ICD for heart failure patients that minimizes hardware and risk while providing optimal diagnostics to help patients feel better and stay out of the hospital. The addition of DX technology to a CRT device is a breakthrough."

The Intica CRT-DX also includes Biotronik’s MultiPole Pacing technology, which was recently approved by the FDA. It allows the left ventricle to be paced twice per cardiac cycle, giving better customization for heart failure therapy.

"BIOTRONIK is disrupting the status quo and setting a new standard of care as we continue to introduce innovations that help hospitals improve outcomes, lower readmissions and take patient care to a new level," said Biotronik President Marlou Janssen in a statement. "Our DX technology is standalone in an industry that knows the rate of complication increases with more leads. Doctors trust and rely on our DX technology because it delivers—less hardware, less complications, paramount diagnostics. We know that the impact of DX is profound for patients and that is why we invested in bringing Intica CRT-DX to market."