Investing.com
Published Apr 08, 2024 08:22
EHRA late-breaking data: Results highlight efficacy, safety, and durability of the novel PFA catheter that is fully integrated with Affera™ Mapping and Ablation System
DUBLIN and
The Sphere-360 catheter was developed with the goal to simplify the atrial fibrillation procedure while enhancing efficiency and providing high durability of lesions. Its unique design includes a large, tissue-conformable lattice tip for efficient energy delivery, with no need to rotate the catheter multiple times in one location as the entire lattice tip delivers PF energy. Furthermore, the catheter is fully integrated with the Affera™ Mapping and Ablation System for complete visualization inside the heart and electroanatomical mapping, making it a true all-in-one single-shot catheter for mapping, ablation, and validation.
The Sphere-360 study, a prospective, single arm, multi-center trial performed in three European centers with a total of 85 patients, demonstrated 81.8% freedom from atrial arrhythmias after one year of follow up, and 100% freedom in the sub-group treated with the optimized and most recent pulse configuration. The treatment time, or first to last PF application, was 10 minutes on average.
A sub-study of patients treated with the optimized pulse underwent remapping procedures; 96% of those patients demonstrated sustained lesion durability, and among all the pulmonary veins (PV) treated in this group, 99% remained isolated after 75 days of the index procedure.
The study also showed the catheter to have a highly favorable safety profile, with zero incidences of primary safety adverse events including esophageal events, pulmonary vein stenosis, phrenic nerve injury or cardiac tamponade.
"Electrophysiologists are seeking innovative catheter options to address the varied cardiac anatomies encountered in patients, and as the population with atrial fibrillation continues to rise, catheter versatility will become more important than ever to achieve the most favorable outcomes," said
The Sphere-360 PFA catheter includes the following:
"We have a vision to continually innovate and bring the best technology to AFib patients around the world, driven by our unwavering commitment to maximizing the safety and efficacy of our products," said
AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.1 AFib is a progressive disease, meaning it can become worse over time and can increase the risk of serious complications including heart failure, stroke and increased risk of death.2-5 Antiarrhythmic drug (AAD) therapy has been the current standard first-line treatment but is ineffective at controlling AFib in approximately half of patients treated with drug therapy.6-8
Worldwide, the single-shot Sphere-360 catheter is investigational and not approved for sale or distribution. The Affera Mapping and Ablation System, which includes the focal Sphere-9™ Catheter and Affera Mapping System, received CE Mark approval in
Based on data on optimized pulse sub-group. Total cohort 90%.
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Leslie Williamson | |
Public Relations | Investor Relations |
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Written By: Investing.com
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