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Biotronik announces FDA approval of ICD systems for patients with HF
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Biotronik announced FDA approval of two implantable cardioverter defibrillator systems for the improvement of care for patients with HF, according to a press release.
The Intica DX and Intica cardiac resynchronization therapy (CRT)-DX ICD systems are cardiac rhythm management devices that eliminate the need for an atrial lead while providing physicians with critical diagnostic information based on a true atrial signal, according to the release.
The launch of Biotronik’s DX technology in 2013 focused on improving patient care and decreasing the rate of complication by minimizing hardware and using diagnostic information, monitoring, managing and preventing cardiac events, the release said.
According to Larry Chinitz, MD, a cardiac electrophysiologist from the NYU Langone Medical Center, physicians are often managing multiple comorbidities that can increase the incidence of complications and risk when implanting a CRT defibrillator.
"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,” he said in the release. “The addition of DX technology to a CRT device is a breakthrough."
The Intica CRT-DX systems include Biotronik’s pacing technology (MultiPole Pacing), which was recently approved by the FDA and enables the left ventricle to be paced twice per cardiac cycle in a sequential and simultaneous fashion.
Disclosure: Chinitz reports receiving fellowship grants from Biotronik.