AF-Only Defibrillator Therapy May Be Five Years Away, Investigator Says
This article was originally published in The Gray Sheet
Implantable defibrillator therapy for the nearly 4 mil. atrial fibrillation patients not requiring ventricular defibrillation is at least three to five years away, Northwestern University electrophysiologist Alan Kadish, MD, indicated at the recent Lehman Brothers Healthcare Conference in Orlando, Florida.
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Medtronic says its Gem III AT dual-chamber implantable cardioverter defibrillator (ICD), approved by FDA via PMA supplement Feb. 13, represents a more compact and powerful alternative to the company's Jewel AF for patients also at risk of atrial tachyarrhythmias. The firm began shipments immediately.
J&J/Cordis' $62.8 mil. cash acquisition of Atrionix rounds out Biosense Webster's electrophysiology product line with a catheter-based ablation approach to atrial fibrillation (AF).
A postmarket surveillance study of Medtronic's Jewel AF (model 7250) implantable cardioverter defibrillator for atrial fibrillation would address concerns about possible complications including death and stroke rate, FDA's Circulatory System Devices Advisory Panel recommended Dec. 5 in Gaithersburg, Maryland.