Medtronic Expands CURE-AF Clinical Program into Europe and Canada
Medtronic, Inc. (NYSE: MDT), today reported the expansion of its CURE-AFSM clinical programa with a post-market study in Europe and Canada. Originally only in the United States, CURE-AF is being conducted to secure U.S. Food and Drug Administration approval of Cardioblate for the investigational treatment of atrial fibrillation (AF). The program will now collect post-market data internationally on the efficacy of irrigated cardiac ablation with radiofrequency (RF) energy in AF patients.
John Liddicoat M.D., general manager of the Structural Heart Disease division, in Medtronic’s CardioVascular business, said, “Research into AF is vital as the clinical community urgently needs proven therapies. AF is the most common cardiac arrhythmia, and is associated with a five-fold increase in a patient’s likelihood of suffering a stroke which can frequently be debilitating and fatal, accounting for one in every 16 American deaths. The more data we have, the better placed we’ll be to ensure that this unacceptably high number is reduced.”
The CURE-AF study is investigating the treatment of AF during an open-heart operation such as valve repair or CABG.b During the procedure, a surgeon uses Medtronic’s Cardioblate System to create a pattern of transmural lesions, i.e., lesions which span the full thickness of heart tissue. The pattern of lesions is modeled after the highly efficacious Cox Maze procedure. Transmurality of the lesions is required for conduction block which, in turn, is essential for the prevention of abnormal conduction associated with AF, and for the potential to restore normal heart rhythm.
The Cardioblate surgical ablation system uniquely achieves consistent transmural lesions with irrigated RF energy. It is currently indicated for cardiac tissue ablation, and has been used in more than 90,000 procedures worldwide.
Dr Alexander Wahba, professor of cardio-thoracic surgery at St. Olavs University Hospital, Trondheim in Norway concluded, “We are delighted to be able to join this research effort. If successful in its objectives, CURE-AF will allow the introduction of a new treatment option for many patients who otherwise might endure an untreated arrhythmia and the considerable associated risks.”
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