Boston Scientific’s LUMINIZE RF Balloon Catheter shows promising results in AF-FICIENT I trial

Boston Scientific has announced that its LUMINIZE Radiofrequency (RF) Balloon Catheter, developed for isolating pulmonary veins (PVs) in atrial fibrillation (AF) treatment, has demonstrated positive safety and efficacy results in the AF-FICIENT I clinical trial. This new device marks an advancement in cardiac ablation technology and its ability to enhance treatment outcomes for patients with AF.

Atrial fibrillation, a condition that causes irregular heart rhythms, is commonly treated with a combination of anti-arrhythmic drugs and cardiac ablation. Cardiac ablation involves the use of energy, such as radiofrequency (RF) energy, to isolate or destroy specific areas of heart tissue causing the abnormal rhythm. The LUMINIZE RF Balloon Catheter employs RF energy, a well-established technique in cardiac ablation, to achieve pulmonary vein isolation, a key step in treating AF.

The catheter itself is equipped with in-built digital cameras for real-time visual guidance, alongside sensing and customizable ablation electrodes on the balloon. These electrodes are capable of adjusting the energy levels around the balloon’s circumference, offering precise control during procedures.

The AF-FICIENT I study, which involved 100 patients suffering from paroxysmal or intermittent AF, was conducted in two phases across multiple centers. The study’s first phase focused on evaluating the original design of the LUMINIZE RF Balloon Catheter, while the second phase assessed improved maneuverability and the addition of dedicated pacing and sensing electrodes. These refinements demonstrated significant improvements in procedural success.

In the first phase of the trial, PV isolation was successfully achieved in 88.9% of veins. However, phase two saw this success rate soar to 99.4%. The second phase also revealed improvements in the catheter’s steering capability, as well as the activation of electrodes. Furthermore, the time spent with the balloon in the left atrium—referred to as balloon dwell time—was reduced from a median of 92 minutes in phase one to just 29 minutes in phase two, contributing to a reduction in overall procedure time from a median of 92 minutes to 71 minutes.

Dr. Amin Al-Ahmad, principal investigator and cardiac electrophysiologist at Texas Cardiac Arrhythmia, stated that the study underscored the benefits of RF energy combined with balloon-based ablation, as demonstrated by the LUMINIZE RF Balloon Catheter. He noted that the data revealed the potential for the catheter to improve both procedural efficiency and patient outcomes.

Kenneth Stein, Senior Vice President and Chief Medical Officer at Boston Scientific, expressed his satisfaction with the trial’s results. He highlighted that the catheter’s ability to provide real-time visualization and control over electrode energy levels could allow physicians to isolate veins more swiftly and accurately, potentially reducing procedure times significantly.

With its innovative design and promising trial results, the LUMINIZE RF Balloon Catheter may pave the way for more effective treatments of atrial fibrillation, offering a compelling solution for both physicians and patients.