Innovation in atrial fibrillation treatment
A growing number of people across the U.S. are developing atrial fibrillation (AF), the most common arrhythmia1. Catheter ablation for AF has shown superior effectiveness over antiarrhythmic drugs in reducing AF recurrences2, however only a small percentage of AF patients receive this treatment today.
Early diagnosis followed by safe and effective ablation treatments can slow disease progression, reduce AF recurrences, and improve patients’ quality of life.3
The burden of atrial fibrillation
12.1 M
U.S. patients with AF by 20304
1 in 7
Strokes caused by AF5
>450k
Hospitalizations with AF annually in US6
Full suite of cardiac ablation therapies.
Boston Scientific is committed to advancing the treatment of Atrial Fibrillation.
FARAPULSE™ Pulsed Field Ablation System
The most clinically proven PFA system is now FDA approved – setting a new standard for treating atrial fibrillation. The FARAPULSE PFA System is purpose-built to optimize the AF procedure and serve the growing AF population.
What is PFA?
Pulsed Field Ablation (PFA) is a non-thermal mechanism of action that has the potential to transform cardiac ablation. Offering several benefits over traditional thermal energy sources, PFA can be optimized to target myocardial tissue while sparing surrounding anatomy.
Why choose FARAPULSE PFA?
FARAPULSE’s proven safety, efficacy, and efficiency are functions of the optimized catheter design, waveform, and dosing strategy.
Unparalleled clinical evidence
- The ADVENT Pivotal Trial, the only randomized controlled trial comparing PFA to cryoablation and radiofrequency ablation, met primary safety and efficacy endpoints while delivering statistically significant improvement in efficiency.7
- MANIFEST-17K is the largest, real-world safety registry of any PFA system.8 In the >17k patients studied, zero cases of:
- Esophageal fistula
- Pulmonary vein stenosis
- Phrenic nerve paralysis
Operational efficiencies
- Standardized, simple workflow
- Flexible imaging guidance and compatible with any mapping system
- Reproducible procedure
Economic value
- 42% average reduction in ablation time7 may increase capacity to add more cases
- Predictable cases improve schedule consistency
Discover how Pulsed Field Ablation with FARAPULSE can positively impact clinical practice and improve efficiencies across your cardiovascular service line.
POLARx™ Cryoablation System
The POLARx Cryoablation System redefines what's possible in cardiac cryoablation. Featuring POLARx™ FIT, the only dual-diameter cryoballoon in one catheter, the POLARx System provides:
- Greater occlusion capability
- Greater ablation confidence
- Greater workflow capabilities
Cardiac ablation resources
References:
1. Centers for Disease Control and Prevention. Atrial Fibrillation. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm. Accessed September 7, 2023.
2. Ang R, Earley MJ. The role of catheter ablation in the management of atrial fibrillation. Clin Med (Lond). 2016;16(3):267-271.
3. Schwennesen HT, Andrade JG, Wood KA, Piccini JP. Ablation to Reduce Atrial Fibrillation Burden and Improve Outcomes: JACC Review Topic of the Week. J Am Coll Cardiol 2023;82:1039-1050.
4. Colilla S, Crow A, Petkun W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol. 2013 Oct 15;112(8):1142-7. doi: 10.1016/j.amjcard.2013.05.063. Epub 2013 Jul 4. PMID: 23831166.
5. Heart Rhythm Society. (2019). Complications from Atrial Fibrillation. Accessed May 9, 2019.
6. Benjamin EJ, Muntner P, Alonso A, et al. Heart disease and stroke statistics—2019 update: a report from the American Heart Association. Circulation. 2019;139(10):e56–528.
7. Reddy, Vivek Y., et al. "Pulsed field or conventional thermal ablation for paroxysmal atrial fibrillation." New England Journal of Medicine 389.18 (2023): 1660-1671.
8. Reddy & Ekanem, et al. Multi-National Survey on the Safety of the Post-Approval Clinical Use of Pulsed Field Ablation in 17,000+Patients (MANIFEST-17K). AHA 2023.