CardioFocus announced today that it initiated clinical trials for its next-generation pulsed field ablation (PFA) technologies.
The company kicked off its CE mark pivotal trial for the QuickShot Nav large-area focal PFA catheter and its next-generation CardioWave PFA system. Dr. Ante Anić leads the study, which enrolled the first patients at KBC Split in Croatia. The initial cases included the first-ever magnetically tracked QuickShot cases.
Marlborough, Massachusetts-based CardioFocus designed QuickShot Nav to support safe, effective and efficient pulmonary vein isolation (PVI) ablation workflows with fewer applications required to achieve flexible lesion sets. It features a magnetic navigation sensor to facilitate compatibility with magnetically enabled electroanatomic mapping systems. QuickShot Nav also utilizes CardioFocus’ patented PFA waveform, Wave 1. The large-area, focal map-and-ablate catheter delivers rapid, effective PFA lesions, including in areas of thick tissue.
The new CardioWave system is a second-generation PFA platform designed for customized waveform delivery, seamless workflow integration and scalable architecture to support future advanced waveforms. The new platform supports all CardioFocus catheters, including it OptiShot balloon for PVI.
In initial procedures, QuickShot successfully worked with several cardiac mapping and navigation systems. Its adaptability reinforces the company’s commitment to versatile PFA workflows that integrate into today’s electrophysiology labs.
The company said its latest advancements strengthen CardioFocus’ position in delivering a platform of next-generation PFA technologies. It aims to combine intelligent waveform design, catheter versatility and advanced visualization to drive AFib ablation therapy.
Commentary from CardioFocus officials and study investigators
Steve Ogilvie, CEO of CardioFocus, said:
“These achievements represent meaningful advancements in our mission to elevate the standards of PFA therapy. With the start of our CE Mark clinical trial treating patients with persistent atrial fibrillation, the successful introduction of the CardioWave Generator, and our integration into magnetic tracking, we’re not only expanding the scientific foundation of our technology but also paving the way for safer, more intuitive ablation workflows across all catheter form factors.”
Anić, head of the Department of Electrophysiology at KBC Split, said:
“We are thrilled to be the first center to initiate this important study. QuickShot offers a unique opportunity to combine efficient PFA energy delivery with real-time contact information. The CardioWave generator allows us to explore the full potential of PFA with adjustable dosing and rapid delivery to better treat patients with the complex lesion sets they need. This is an exciting advancement for electrophysiologists and patients with atrial fibrillation seeking interventional treatment.”
