Cardiovascular Business Week
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CryoCath Technologies, Inc.
FDA approves Arctic Front IDE for the treatment of atrial fibrillation
April 26th, 2005
CryoCath Technologies, Inc., the global leader in cryotherapy products to treat cardiovascular disease, announced it has received clearance from the United States Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) study for the treatment of atrial fibrillation (AF). The study will see the use of two CryoCath catheters, Arctic Front to treat AF and Freezor MAX to treat Atrial Flutter when concomitant to AF. The initial stage of this trial will treat approximately 25 AF patients at 3 U.S. centers, with enrollment completed by the end of the second quarter of calendar 2005. Initial 3-month follow-up data is expected...
Source: Cardiovascular Business Week (2005-04-26)
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