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Amplatzer Talisman PFO Occluder | PFO Closure …

    https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-pfo.html
    The Amplatzer™ Talisman™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude other causes of ischemic stroke.

AGA Medical Amplatzer Trial For PFO To Start By Q3, …

    https://medtech.pharmaintelligence.informa.com/MT016397/AGA-Medical-Amplatzer-Trial-For-PFO-To-Start-By-Q3-Expanding-On-HDE
    AGA Medical plans to seek full PMA approval of its Amplatzer occluder system for patent foramen ovale (PFO) following receipt of limited approval via …

Amplatzer PFO Occluder | Centennial Heart …

    https://centennialheart.com/patient-center/patient-education/amplatzer.dot
    U.S.A. Humanitarian Use Device The AMPLATZER PFO Occluder is authorized by Federal law for the non-surgical …

Info on the Withdrawal of Two HDEs For Patent Foramen …

    https://www.fda.gov/medical-devices/humanitarian-device-exemption/information-physicians-and-patients-withdrawal-two-humanitarian-device-exemptions-hdes-patent
    A PFO is a tunnel-like opening between the two upper chambers of the heart, the right and left atria. This opening is formed during the development of the heart in utero, and in most …

St Jude Medical acquires AGA Medical - NS Medical Devices

    https://www.nsmedicaldevices.com/news/st-jude-medical-acquires-aga-medical_221110
    St Jude Medical has completed the acquisition of AGA Medical, a developer of interventional devices for the minimally invasive treatment of structural heart …

THE List - MRI Safety

    http://www.mrisafety.com/TMDL_list.php?mastertable=SafetyInformation&masterkey1=191
    Patent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), Ventricular Septal Defect (VSD) Occluders, and Patent Foramen Ovale Closure Devices. Cardiac occluders and …

Patent Foramen Ovale Closure for Stroke …

    https://www.ahajournals.org/doi/10.1161/JAHA.117.007146
    New‐onset periprocedural AF is a known complication of percutaneous PFO closure with an incidence of up to 3.9% from a large series of 1349 …

Patent Foramen Ovale (PFO) - Centennial …

    https://centennialheart.com/patient-center/patient-education/pfo.dot
    If a Patent Foramen Ovale is found in conjunction with an unknown source of stroke, you may be referred for medical treatment or AMPLATZER device closure of your PFO. …

AGA Medical RESPECT Amplatzer PFO Trial To Include 500-800 …

    https://medtech.pharmaintelligence.informa.com/MT018647/AGA-Medical-RESPECT-Amplatzer-PFO-Trial-To-Include-500-800-Patients
    AGA Medical RESPECT Amplatzer PFO Trial To Include 500-800 Patients This article was originally published in The Gray Sheet 07 Jul 2003 Executive Summary …

Instructions for Use - Food and Drug Administration

    https://www.fda.gov/media/97980/download
    Perform an angiogram to demonstrate the PFO. Catheterize the left atrium using a 45° LAO position and cranial angulation of 35°–45°. Inject contrast medium into the right upper …



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