The CoolLoop® cryoablation catheter targets a significant market: Atrial fibrillation (AF) is the most common cardiac rhythm disease today. More than 14 million people in the industrialized world are affected by AF. AF affects 1–2% of the population, and its prevalence is estimated to at least double in the next 50 years as the population ages. The prevalence of AF increases with age, from 0.5% at 40–50 years, to 5–15% at 80 years. The lifetime risk of developing AF is approximately 25% in those who have reached the age of 40.
AF is associated with increased rates of death, stroke and other thrombo-embolic events, heart failure and hospitalizations, impaired quality of life, reduced exercise capacity, and left ventricular dysfunction. Death rates are doubled by AF, independently of other known predictors of mortality. Stroke in AF is often severe and results in long-term disability or death. Approximately every fifth stroke is due to AF. Quality of life and exercise capacity are impaired in patients with AF. Patients with AF have a significantly poorer quality of life compared with healthy controls, the general population, or patients with coronary heart disease in sinus rhythm. Hospitalizations due to AF account for one-third of all admissions for cardiac arrhythmias and thus pose a significant economic burden to the healthcare system.
Current therapies focus on pharmaceutical drugs to maintain sinus rhythm. However, these do not address the underlying cause of the disease, have limited therapeutic effect and side effects. Over the last decade, catheter ablation has emerged as a minimally invasive treatment option. By developing safe, efficient and simple tools, AFreeze will provide physicians, patients and hospitals with new treatment options that really make a difference.
Disclaimer: Investigational device. Regulatory approval of the AFreeze cryoablation system is pending and is presently not for sale in any territory..
Every patient who presents with AF for the first time is considered a patient with first diagnosed AF, irrespective of the duration of the arrhythmia …