Farapulse announced that it has received the CE mark for its pulsed field ablation (PFA) system for the treatment of paroxysmal atrial fibrillation (AF). The approval will allow the company to commercialise the cardiac PFA system and permits marketing of the system across the European Union and other CE mark geographies.
Farapulse said in a press release that it will partner with a select number of physicians prior to a broader rollout of the device.
“Farapulse PFA has garnered a high level of interest at scientific symposia in the past several years, making it abundantly clear that the medical community is primed to adopt our technology into routine use. The clinical results and unparalleled volume of data chronicled through investigator-authored abstracts and manuscripts have been exceedingly well received,” said Allan Zingeler, president and CEO of Farapulse. “Europe’s modern and progressive electrophysiology market represents a unique opportunity for Farapulse to showcase our PFA system’s powerful yet incredibly safe ability to lead in the treatment of AF.”
“Based on my own multi-year experience with the Farapulse system and the compelling results from the company’s comprehensive clinical programme, I believe PFA will define a new era in the ablation of AF and possibly other arrhythmias,” said Pierre Jaïs, Bordeaux University Hospital, Electrophysiology and Heart Modeling Institute (LIRYC), Bordeaux, France. “In more than 160 procedures performed across Europe, the system has surpassed all expectations with respect to safety, effectiveness, efficiency and ease-of-use. It will be exciting to welcome this ground-breaking technology into our clinic, especially as the potential for fatal oesophageal fistula has been in the back of our minds for decades, and now this risk is significantly mitigated with Farapulse’s technology.”
The CE mark confirms that the Farapulse PFA system meets all requisite quality standards for safety, design, manufacture and final inspection. In September 2020, Boston Scientific announced an expanded investment in Farapulse and secured an exclusive option to acquire the company.