Boston Scientific said that its LUMINIZE Radiofrequency (RF) Balloon Catheter (LUMINIZE RF Balloon Catheter), which is intended to be used for isolating pulmonary veins during treatment of patients with atrial fibrillation (AF), has achieved positive safety and efficacy results in the AF-FICIENT I clinical trial.
Atrial fibrillation patients are usually treated with anti-arrhythmic drugs and cardiac ablation.
The LUMINIZE RF Balloon Catheter utilizes radiofrequency energy, which is the most widely used energy source for cardiac ablation procedures. Radiofrequency energy is used for isolating areas of heart muscle that cause abnormal heart rhythm.
The LUMINIZE RF Balloon Catheter is a single-shot catheter with in-built digital cameras for visual guidance.
The medical device has sensing electrodes on the balloon to evaluate isolation of veins in real-time vein and also ablation electrodes that can be customizable. The ablation electrodes are capable of producing customized levels of energy around the balloon’s circumference.
The globally held AF-FICIENT I study, in two phases, assessed acute procedural success and safety of single-shot LUMINIZE RF Balloon Catheter. A total of 100 patients with symptoms of paroxysmal or intermittent Atrial Fibrillation were enrolled in the prospective, non-randomized, multi-center study.
In the phase one study, the original designs of the device was tested and in the phase two study, changes to improve maneuverability, and the addition of dedicated pacing and sensing electrodes were evaluated.
Amin Al-Ahmad – principal investigator and cardiac electrophysiologist at Texas Cardiac Arrhythmia in Austin, Texas said that: “The study assessed the safety and effectiveness of isolating PVs through the combined benefits of RF and balloon-based ablation, both of which are found in the LUMINIZE RF Balloon Catheter.
“The data underscore the potential for this catheter to improve procedural efficacy and patient outcomes.”
PV isolation was achieved in 88.9% of veins during the phase one study and in the phase two study, it surged to 99.4% of veins while the steering capability was shown to be improved and activation of electrodes activated.
In addition to it, balloon dwell time, which is the median time the balloon was in the left atrium, was reduced from 92 minutes in the phase one study to 29 minutes in phase two, thus reducing the total procedure time to a median 71 minutes.
Kenneth Stein – senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific said: “We are pleased with the data presented today as it highlights the potential benefits of the LUMINIZE RF Balloon Catheter”.
“By providing real-time visualization both before and during ablation and individualized control of electrode energy levels, this technology may allow physicians to swiftly and accurately isolate veins and decrease procedure times.”