CardioFocus has treated the first patients in an investigational trial of OptiShot, its pulsed field ablation (PFA) system for treating paroxysmal atrial fibrillation (AF).
The patients in the Massachusetts, US-based company’s VISION AF trial were treated by Dr Vivek Reddy, director of cardiac arrhythmia services at Mount Sinai Hospital, and Petr Neužil, chief of cardiology at the Na Homolce hospital in Prague, Czechia.
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Up to 50 patients are set to betreated in the trial in the coming months, with 12-month follow-ups planned to include critical remapping procedures for CardioFocus to validate the efficacy of the technology.
According to CardioFocus, the ultra-compliant balloon in the PFA system enables tissue contact and precise anatomic delivery of pulsed energy for AF treatment.
Dr Vivek Reddy said: “The OptiShot balloon catheter is unique among the advanced generation of PFA catheters, with its ability to deliver circumferential lesions to the pulmonary veins with endoscopic visual confirmation of electrode-tissue contact.
“Direct contact confirmation made me more confident that our acute treatment strategy with this system may provide good long-term outcomes.”
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By GlobalDataCardioFocus CEO Steve Ogilvie said that in creating OptiShot, the company has combined expertise in pulsed field waveforms with its balloon system as seen in CardioFocus’s other devices including the HeartLight X3 system for pulmonary vein isolation (PVI) procedures, which it gained a CE mark for in 2019.
“We are one step closer toward providing a true single shot pulmonary vein isolation tool, designed for safe and effective patient treatment,” said Ogilvie.Elsewhere in PFA, earlier this month US-based Field Medical secured breakthrough device designation from the US Food and Drug Administration (FDA) for the FieldForce ablation system, and the Texas Cardiac Arrhythmia Institute (TCAI) at St David’s Medical Center became the first clinic in the US to use Medtronic’s Affera mapping and ablation system with the Sphere-9 catheter since the FDA approved the device in October 2024.
