This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: AMPLATZER® Muscular VSD Occluder
PMA Applicant: AGA Medical Corporation
Address: 5050 Nathan Lane, Plymouth, MN 55442, USA
Approval Date: September 7, 2007
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040040a.pdf
What is it? The AMPLATZER ® Muscular VSD Occluder is a device placed via a catheter into the muscular ventricular septum, which separates the two ventricles of the heart, in order to close a hole, known as a ventricular septal defect (VSD).
The device consists of two parts: (1) a delivery system and (2) a permanent implant. The delivery system helps transport the implant to the site of the defect in the heart. The implant is the part of the device that remains in the heart to block the hole. The implant is a self-expandable double disc made from wire mesh and polyester fabric.
|How does it work? A doctor makes a small incision in the groin and threads the delivery system and implant through blood vessels to the heart. Inside the heart, the device is advanced to the site of the defect. When the doctor is certain the device is placed properly, the implant is released from the delivery system and opened so that the defect is blocked (or sandwiched) by the mesh discs. The implant remains in the heart and the delivery system is removed. Once the device is in place, tissue will grow over it closing the defect. The device then becomes part of the wall of the heart.|
When is it used? The AMPLATZER® Septal Occluder is intended to close openings between the ventricles (the two lower chambers of the heart). It can be used to treat patients with certain types of muscular ventricular septal defects when surgery is believed to be “high risk” based on anatomical conditions and/or based on overall medical condition.
What will it accomplish? In the majority of patients, the implant will permanently close the defect in the heart without open-heart surgery.
When should it not be used? The Amplatzer® VSD Occluder should not be used in patients who:
- have defects less than 4 mm distance from the heart valves;
- have very high and/or irreversible pulmonary vascular disease;
- have perimembranous or post-infarction VSDs;
- weigh < 5.2 kg;
- have sepsis or an active bacterial infection; and
- have contraindications to anti-platelet therapy.
Additional information: The Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040040