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Amplatzer® PFO Occluder | | | General Information | |
| Vendor | | AGA Medical Corporation | | Item | | Amplatzer® PFO Occluder | | Approval | | Available only as an investigational device in the US
Device is available outside the US | | Product Number | | 9-PFO-HDE-0189-PFO-HDE-0259-PFO-HDE-035 | | Intended Use | | In USA the Amplatzer PFO Occluder is authorized by Federal law for the non-surgical closure of a patent foramen ovale (PFO) in patients with recurrent cryptogenic stroke due to presumed paradoxical embolism through a patent foramen ovale and who have failed conventional drug therapy. The effectiveness of this device for use in this indication has not yet been demonstrated. Outside USA the Amplatzer PFO Occluder is a percutaneous, transcatheter occlusion device intended to close all types of PFO's (i.e., classical as well as those with aneurysm of the septum) in patients with a history of stroke or transient ischemic attacks (TIA's). | | Device Size = RA Disc Diameter | | 18 mm, 25mm, 35mm | | Recommended Sheath Size | | 8 French, 45º Curve+ | | Pricing |  | Inquire | | Financing | | To finance this purchase click here (U.S. customers only) |
| | Related Content | |
| | Product Description | |
| Amplatzer PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. The two discs are linked together by a short, connecting waist, allowing free motion of each disc. In order to increase its closing ability, the discs contain thin polyester fabric. This fabric is securely sewn to each disc by a polyester thread. Amplatzer PFO Occluder has been developed to be potentially used as an alternative to either open heart surgery or anticoagulant/antiplatelet therapy. Currently, these are the two measures most commonly taken to prevent further recurrences in patients with PFO and paradoxical cerebral emboli. | |
| AGA Medical Corporation | | Customer Service: (888) 546-4407 | | Please mention Medcompare.com when you contact the vendor. |
| NOTE: Medcompare disclaims any information on this site. The information found on Medcompare (Drug Guide, Product Listings and otherwise) is intended for use by medical professionals. This information is not intended to replace the information, advice or instructions from a medical doctor. Pricing information is approximate, actual prices may vary. |
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