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AMPLATZER™ Septal Occluder
en: Instructions for Use
Device Description
The AMPLATZER™ Septal Occluder is a self-expanding nitinol mesh, double-disc occlusion
device for use in atrial septal defects. The 2 discs are connected by a short waist with a waist
diameter that corresponds to the atrial defect size. To increase its closing ability, the device is filled
with polyester fabric that is securely sewn to each disc by a polyester thread. Radiopaque marker
bands at each end of the device provide visualization under fluoroscopy.
The AMPLATZER™ 45° Delivery System was designed to facilitate attachment, loading, delivery,
and deployment of the AMPLATZER™ Occluders and is composed of:
• Delivery sheath with hemostasis valve – provides a pathway through which an
AMPLATZER™ device is delivered
• Dilator – eases penetration of tissue and minimizes vessel trauma
• Loader – introduces an AMPLATZER™ device into the sheath
• Plastic vise – attaches to the delivery cable and serves as a handle for disconnecting
(unscrewing) the delivery cable from a device
• Delivery cable – attaches to the device to control its movements through the sheath
Refer to the figures and tables on the foldout of the back cover for more information about the
device. Device and delivery sheath dimensions are provided in table T1. The following device
components are identified in the figures.
Indications and Usage
The AMPLATZER™ Septal Occluder is a percutaneous, transcatheter atrial septal defect closure
device intended for the occlusion of atrial septal defects (ASDs) in secundum position or patients
who have undergone a fenestrated Fontan procedure and who now require closure of the
fenestration.
Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial
septal defect and clinical evidence of right ventricular (RV) volume overload (ie, 1.5:1 degree of
left-to-right shunt or RV enlargement).
Contraindications
The AMPLATZER™ Septal Occluder is contraindicated for:
• Patients known to have extensive congenital cardiac anomaly that can only be adequately
repaired by cardiac surgery.
• Patients known to have sepsis within 1 month prior to implantation, or patients with any
systemic infection that cannot be successfully treated before device placement.
• Patients known to have a bleeding disorder, untreated ulcer, or any other contraindications to
aspirin therapy, unless another antiplatelet agent can be administered for 6 months after
device placement.
• Patients who are unable to take antiplatelet or anticoagulant therapy.
• Patients known to have demonstrated intracardiac thrombus on echocardiography
(especially left atrial or left atrial appendage thrombi).
Figure F1
Figure F2
A.
Device waist diameter
E.
Loader
B.
Left atrial disc
F.
Hemostasis valve
C.
Right atrial disc
G.
Delivery sheath
D.
Device waist length
H.
Dilator
I.
Delivery cable
J.
Plastic vise
100092311_ASD.book Page 1 Monday, January 6, 2014 11:00 AM
