DUBLIN – April 6, 2016 – Medtronic recently announced positive results for a landmark “ice and fire†clinical study confirming frozen balloon ablation for patients with symptomatic paroxysmal atrial fibrillation ( The Arctic Front series is not inferior to RF ablation (ThermoCool series) in terms of safety and effectiveness. The findings were published at the 65th Annual Meeting of the American College of Cardiology (ACC) and published in the New England Journal of Medicine. The results confirm that frozen balloon ablation is a short, safe and effective ablation method.
Professor Karl-Heinz Kuck of the Klinik St. Georg Hospital in Asklepios, Hamburg, Germany, is a principal investigator in ice and fire research. He said: "Through this design rigorous study, we found that frozen balloon ablation is not only inferior to radiofrequency ablation, the current standard of therapy, but also effective in the ablation core process, cryoablation ablation, a simple and intuitive surgical procedure. Let more patients with atrial fibrillation benefit from it."
The study reached its primary efficacy endpoint, showing radiofrequency ablation of frozen balloon ablation versus three-dimensional navigation (p=0.0004) without the use of a three-dimensional mapping system, reducing arrhythmia recurrence, requiring medication and/or re-ablation No inferiority. The study also reached its primary safety endpoint, namely all-cause death, all-cause stroke/transient ischemic attack, and treatment-related adverse events. The incidence of complications in both ablation methods was relatively low. Frozen balloon ablation (mean 124 min) was shorter than radiofrequency ablation (mean 141 min, P=0.0001), and exposure time was longer than radiofrequency ablation (radiofrequency average exposure time 17 min, cryoablation average exposure 22 min, P=0.0001).
Pulmonary veins are a source of irregular electrical signals that cause atrial fibrillation, and isolated pulmonary vein (PVI) is the standard method for treating patients with atrial fibrillation. Cryopreservation uses a cryogen to cause continuous annular damage to achieve pulmonary vein isolation; radiofrequency ablation uses thermal energy (RF energy) to simultaneously perform three-dimensional mapping and point-by-point ablation to achieve pulmonary vein isolation.
The "Ice and Fire" study is the largest multicenter clinical randomized controlled trial comparing two atrial fibrillation ablation methods to date, cryoablation (ice), use of Arctic Front or Arctic Front Advance cryosphere; radiofrequency ablation (fire), application One of the three cool brine conduits of the ThermoCool series under 3D navigation, including the ThermoCool® cold brine conduit, the ThermoCool® SF cold brine conduit and the ThermoCool® SmartTouch® pressure-sensing cold brine conduit. The Ice and Fire study enrolled 769 patients from 16 large medical centers in Europe. All patients were diagnosed with paroxysmal atrial fibrillation. Antiarrhythmic drug therapy was ineffective. Pulmonary vein isolation was followed for 33 months after the first ablation (average about 1.54). year). Inferiority research designs are often used to compare new technologies with currently accepted mainstream technologies.
Colleen Fowler, general manager and vice president of the atrial fibrillation business at Medtronic's Cardiovascular Business Group, said that the largest head-to-head comparative study of two atrial fibrillation treatments – the “ice and fire†study reveals how safe and effective atrial fibrillation is ablated. An important clinical point of view, whether for patients or doctors, the effect of cryoablation is very beneficial. As the world's population ages, there is a growing need for safe, clinically effective, and efficient treatments. Today's data will further support the global adoption of cryoablation, a milestone in helping patients choose the optimal treatment. The Arctic Front cryoablation system has been used in 180,000 operations in more than 50 countries around the world. In the United States, Arctic Front Advance has been approved for the treatment of drug-ineffective, recurrent episodes of symptomatic paroxysmal atrial fibrillation, which is approved for the treatment of all atrial fibrillation in Europe.
About AF
Atrial fibrillation is one of the most common and under-treated arrhythmias in the clinic. There are 33.5 million patients worldwide. Nearly half of the patients have no medical treatment. If atrial fibrillation is developed, the risk of stroke in patients with atrial fibrillation is 5 Times, it is easier to develop into heart failure.
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