Amplatzer Muscular VSD Occluders | 合法醫療器材資訊網

Amplatzer™MuscularVSDOccluder.TheAmplatzer™MuscularVSDOccluderisintendedfortheclosureofcongenitalventricularseptaldefectsinhigh-risk ...

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Important Safety Information

Indication for Use

The Amplatzer™ Muscular VSD Occluder is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure (large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.

High-risk anatomical factors for transatrial or transarterial surgical closure include patients: Requiring left ventriculotomy or an extensive right ventriculotomy; With a failed previous VSD closure; With multiple apical and/or anterior muscular VSDs (“Swiss cheese septum”); Wi...