Boston Scientific: Positive Safety, Efficacy Data for LUMINIZE RF Balloon Catheter

Boston Scientific Corporation (NYSE: BSX) announced data from the AF-FICIENT I study during a late-breaking clinical trial session today at EHRA 2019, the annual congress of the European Heart Rhythm Association in Lisbon, Portugal. The data demonstrated positive safety and efficacy results with the LUMINIZE™ Radiofrequency (RF) Balloon Catheter for isolation of pulmonary veins (PV) when treating patients with atrial fibrillation (AF).  

Patients with arrhythmias such as AF are often treated with anti-arrhythmic drugs as well as cardiac ablation. The LUMINIZE RF Balloon Catheter uses RF energy – the most common energy source for cardiac ablation procedures – to isolate the areas of the heart muscle responsible for the abnormal heart rhythm. The single-shot catheter also features built-in digital cameras for visual guidance, sensing electrodes on the balloon to assess real-time vein isolation and customizable ablation electrodes with the ability to deliver tailored levels of energy around the circumference of the balloon.

The global AF-FICIENT I study examined acute procedural success and safety for the single-shot LUMINIZE RF Balloon Catheter in two phases. Phase one tested the original design of the device and phase two included changes to enhance maneuverability and add dedicated pacing and sensing electrodes. Phase one study data showed PV isolation was achieved in 88.9% of veins. In phase two, with the enhanced steering capability and electrodes activated, PV isolation increased to 99.4% of veins. Additionally, the median time the balloon was in the left atrium – known as balloon dwell time – decreased from 92 minutes in phase one to 29 minutes in phase two, bringing the total procedure time down to a median 71 minutes.

“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,” said Amin Al-Ahmad, M.D., principal investigator and cardiac electrophysiologist at Texas Cardiac Arrhythmia in Austin, Texas. “The data underscore the potential for this catheter to improve procedural efficacy and patient outcomes.”

https://www.marketscreener.com/BOSTON-SCIENTIFIC-CORPORA-11935/news/Boston-Scientific-Late-breaking-Clinical-Trial-Highlights-Positive-Safety-and-Efficacy-Data-for-th-28181662/