Medical Review - Experimental/Investigational

Repair of Foramen Ovale with Septal Occluder Device

Description
A patent foramen ovale, or PFO, is an opening between the upper two chambers of the heart that have failed to close after birth. This congenital defect is also known as “hole in the heart” and affects about 25 percent of the population. A device inserted through a vein in the leg or neck is made of nickel-titanium alloy “nature's liquid metal” and designed to accommodate variations in anatomy. Current recommendations for using this device are for those who have failed medical therapy or are poor candidates for Coumadin. The device limits the recurrence rate of clots.

Policy
The septal occluder device is experimental/investigational for foramen ovale due to the lack of scientific literature to support its use and FDA approval.

CPT Codes
93580
93581

Determined by the Pediatric Liaison committee at the 07-31-02 meeting and approved by the Medical Advisory Committee in November 2002.

(Web updated 2/2005)

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