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Medtronic Cryoablation Superior to Drug Therapy for Symptomatic Paroxysmal Atrial Fibrillation | ||
By: GlobeNewswire - 29 Aug 2020 | Back to overview list |
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ESC Congress: New Research Highlights First-Line Use of Cryoablation as Highly Effective, and with Improved Quality of Life Scores DUBLIN, Aug. 29, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced clinical trial results demonstrating superiority of the Arctic Front™ Advance Cardiac Cryoballoon and Freezor® MAX Cardiac CryoAblation Catheter for the first-line treatment (prior to drug therapy) of recurrent symptomatic paroxysmal atrial fibrillation (PAF) compared to antiarrhythmic drug (AAD) treatment. Primary results of the randomized STOP AF First trial were presented as a late breaking clinical trial at the European Society of Cardiology (ESC) Congress 2020 Digital Experience. Additionally, 12-month outcomes from the Cryo-FIRST trial showed a significant improvement in atrial fibrillation-related quality of life with the use of the Medtronic cryoablation system compared to anti-arrhythmic drug therapy in patients who had not previously received antiarrhythmic drugs to treat their symptomatic PAF. Atrial fibrillation (AF) is a progressive condition that impacts more than 33 million people worldwide.1 Without early intervention, progression of the condition is associated with a higher rate of cardiovascular admissions,2 heart failure hospitalization,3 and mortality,4 along with a reduced quality of life.5 Antiarrhythmic drug therapy is currently the standard first-line treatment for patients with AF; however, AF recurs in approximately 50% of patients treated with AADs within a year of therapy onset. In addition, AAD therapy frequently causes side effects that can lead many patients to discontinue treatment.6 Cryoablation uses cold energy (freezing) delivered through an inflatable balloon to create scar tissue to interrupt unwanted electrical pathways in the heart. STOP-AF First Primary Results Results showed superiority of cryoablation for maintaining freedom from AF, atrial tachycardia and atrial flutter, with treatment success achieved in 75% of patients in the catheter ablation group versus 45% in the AAD group (P<0.0001). Furthermore, the trial revealed a low rate of safety events with catheter ablation as a first-line therapy (1.9%). Previous studies have consistently demonstrated a low rate of serious complications with cryoablation in drug refractory patients; the STOP AF First study furthers these observations specifically to patients who had not previously received antiarrhythmic drugs to treat their symptomatic PAF.7,8 Cryo-FIRST Quality of Life Results New quality of life findings from the trial, also presented at ESC 2020, showed the Medtronic cryoablation solution resulted in a significant improvement in AF-specific, health-related quality of life at 12 months compared to AAD therapy. “More than half of patients with symptomatic AF do not experience a reduction in AF with antiarrhythmic drugs, effectively delaying their therapy and leaving a critical need for an alternative first-line treatment,” said Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm and Heart Failure and the Cardiac Ablation Solutions divisions, which are part of the Cardiac and Vascular Group at Medtronic. “Not only do the STOP AF First findings show cryoablation is a potential first-line treatment for these patients, the Cryo-FIRST results show encouraging benefits of this treatment approach on these patients’ quality of life.” The Arctic Front Advance Cryoablation System is approved in Europe for the treatment of AF. The United States Food and Drug Administration (FDA) recently expanded the indication for Medtronic cryoablation therapy to include treating patients with symptomatic, recurrent persistent AF, in addition to patients with drug refractory, recurrent, symptomatic paroxysmal AF. Results of the STOP-AF First trial have not been reviewed by the FDA. “The strong evidence from these trials will help bring cryoablation treatment to more patients suffering from AF earlier in the course of their disease,” said Rebecca Seidel, vice president and general manager of Cardiac Ablation Solutions. “Medtronic has very robust clinical evidence supporting the Arctic Front Family of Cardiac Catheters as a first line therapy for paroxysmal AF, and for paroxysmal and persistent AF patients whose condition is unresponsive to drug therapy.” In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world. About Medtronic Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. -end- 1 Chugh S, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014; 129:837-847. Lauren Mueller Ryan Weispfenning |
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