Issue link: https://beckershealthcare.uberflip.com/i/777561
AF SOLUTIONS CRYOBALLOON HIGHLIGHTS AF Ablation Clinical Trial FIRE AND ICE SM In a predefined analysis: Compared to Radiofrequency Patients Treated with Cryoballoon Experienced Significantly Better Outcomes Payer Cost Savings *4 § $355K total § $925 per patient Asymptomatic 40% 8 Failed Rx Ablation Candidate 30% 7 ~ 4% treated annually 1 Rx Effective 30% Why Treat AF? ¡ AF is the most common arrhythmia with global prevalence > 33 million. 5 ¡ AF ablation is a relatively underpenetrated therapy. ¡ According to 2006 estimates the economic cost to care for AFib patients in the United States was ~ $26 billion per year. The total cost of care for a patient who has AF is ~ $8,700 higher per year as compared to people who do not have AF. 6 ¡ Pulmonary vein isolation (PVI) is the cornerstone of AF ablation strategy. 7 Why CRYOBALLOON? ¡ Cryoballoon has become a mainstream therapeutic option for treating AF. ¡ Cryoballoon provides a simple solution for our customers, allowing them to consistently achieve: – Excellent efficacy and strong safety outcomes – Shorter, more consistent procedures ¡ 2015 Revised ACC/AHA/HRS Fellows Training Guidelines Recommend Cryoablation Training 8 ¡ To date, > 220,000 9 Cryoballoon procedures have been performed globally. Establishing a new gold standard in AF Ablation ¡ FIRE AND ICE is the largest multicenter, randomized prospective comparison of AF ablation technologies 1 ¡ Cryoballoon met the non-inferiority efficacy endpoint, the safety endpoints, and did so with shorter and more consistent procedure times as compared to radiofrequency catheter ablation, as published in the New England Journal of Medicine 2 ¡ The predefined secondary analyses favor cryoballoon over radiofrequency catheter ablation, with important implications on daily clinical practice. Patients treated with cryoballoon experienced significantly fewer repeat ablations and CV hospitalizations compared to radiofrequency catheter ablation, as published in European Heart Journal 3 ¡ Fewer repeat ablations and CV hospitalizations led to significantly lower payer costs for the cryoballoon patients over the trial period * compared to the radiofrequency group 4 Arctic Front Advance ™ Cryoballoon 1/3 Fewer 3 § Cardiovascular- related Hospitalizations § Repeat Ablation Procedures * U.S. Healthcare System Trial period (Mean follow-up of 1.5 years and maximum follow-up of 33 months)