CardioFocus Announces First-in-Human Use of OptiShot: World’s First Endoscopic Ultra-Compliant Balloon PFA Catheter for Atrial Fibrillation

Dec 18, 2024 22:15 CST Updated 22:15

CardioFocus

Cardiac Medical Device Manufacturer

CardioFocusAnnouncing its super-compliant balloon-type PFA catheter---OptiShotCompletion of the First Patient Cohort Enrollment (VISION AF), this is the second clinical study of a balloon-shaped PFA catheter in the United States.VISION AF Clinical StudyOptiShotThe FIM will enroll 50 patients with atrial fibrillation across multiple centers in Europe and the United States, with a 12-month follow-up to validate.OptiShotSafety and effectiveness.

PI Evaluation

"OptiShot is unique among the advanced generation of PFA catheters, as it can deliver circumferential lesions to the pulmonary veins with endoscopic visual confirmation of electrode-tissue contact."Direct contact confirmation gives me more confidence that our acute treatment strategy using this system may provide good long-term outcomes.”

---Vivek Reddy Mount Sinai Hospital

"The super-compliant balloon can adapt to all anatomical structures through unparalleled tissue contact and precise pulsed electric field energy delivery. The focus of this design is to improve patient outcomes, and we look forward to continuing this research."

---Petr Neužil Na Homolce Hospital

Executive Evaluation

"CardioFocus combines our expertise in pulsed field waveforms with our clinically proven compliant balloon to create OptiShot, the next-generation PFA system for treating atrial fibrillation. We are one step closer to delivering a true single-shot pulmonary vein isolation tool designed for safe and effective patient treatment. We thank our electrophysiologist partners as well as the CardioFocus team and consultants for this outstanding achievement."

----Steve Ogilvie, CEO of CardioFocus

The competition in PFA has entered a white-hot stage, and the demand for innovation in PFA catheters and energy platforms is also increasing. Without absolute technical advantages, it will be difficult to compete overseas in the future. Currently, PFA products approved by the FDA all have various advantages. Of course, these PFAs are not perfect and still have significant room for improvement and optimization.

CardioFocusAs a star company in the era of electrophysiology thermal ablation, it has secured a place in the highly competitive electrophysiology field with a laser ablation balloon catheter product featuring camera functionality. However, with the advent of the PFA era, whether it is radiofrequency, cryoablation, or laser, all lack competitiveness compared to PFA. ThereforeCardioFocusIt also has to face transformation. For this reason, it acquiredGalvanize Therapeutics' electrophysiology technology department, thereby acquiring the advanced PFA energy platform CENTAURI PEF (this is the second CE-approved PFA energy platform to be marketed, following only Boston Scientific).

With an energy platform, there is a need for innovative PFA ablation catheters.CardioFocusIntegrating its advanced laser ablation catheter, HeartLight X3 technology, into the PFA ablation system, thereby creating the world's first and only endoscope-equipped, ultra-compliant balloon-shaped PFA catheter ---OptiShot。

OptiShotNot only does it achieve tight contact between the myocardial tissue of the pulmonary veins and the vestibule with the two announced balloon-shaped PFA catheters, but it also allows for confirmation of whether the electrodes on the balloon surface are in close contact with the tissue through an endoscope. This enables true one-shot complete ablation.

HeartLight X3

CardioFocus

CardioFocusIs a medical device innovator and manufacturer dedicated to advancing ablation treatments for the most common arrhythmias, such as atrial fibrillation (AFib).HeartLightIt is a revolutionary catheter ablation technology characterized by a super-compliant balloon, direct visualization, and titratable laser energy, representing a new standard for AFib ablation.