Boston Scientific has announced positive results from the AF-FICIENT I study that evaluated the safety and efficacy of its Luminize Radiofrequency (RF) Balloon Catheter.
The single-injection catheter is designed to isolate the pulmonary veins (PV) when treating patients with atrial fibrillation (AF). The device identifies the areas of the heart muscle that are responsible for abnormal heart rhythms using RF energy.
The Luminize RF Balloon Catheter features integrated digital cameras for visual guidance, customisable ablation electrodes, and sensing electrodes that are capable of evaluating vein isolation in real-time.
Boston Scientific rhythm management and global health policy senior vice-president and chief medical officer Kenneth Stein said: “By providing real-time visualisation both before and during ablation, and individualised control of electrode energy levels, this technology may allow physicians to swiftly and accurately isolate veins and decrease procedure times.”
The global non-randomised, multi-centre AF-FICIENT I study enrolled a total of 100 patients with symptoms of paroxysmal or intermittent AF. The trial examined acute procedural success and safety in two phases.
The standard device was tested in the first phase, while the second phase trialled a unit that had been changed to comprise improved manoeuvrability and additional pacing and sensing electrodes.
Phase I study data showed PV isolation in 88.9% of veins, while Phase II saw 99.4%. No device-related serious adverse events were found in either phase.
With the addition of the cryoballoon platform, the company will have both cryothermal and RF single-shot, balloon-based ablation therapies in its portfolio.