AMPLATZER® Septal Occluder 缺损封堵器

Product Name: AMPLATZER® Septal Occluder
Manufacturer: AGA Medical Corporation
Address: 682 Mendelssohn Avenue, Golden Valley, MN 55427
Approval Date: December 5, 2001 
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000039a.pdf

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 disk made from wire mesh and polyester fabric.

这种装置包含两部分：1，输送系统；2，永久置入装置。输送系统可将封堵器送至心脏缺损位置。封堵器留在心脏内并封堵缺损。这种封堵器由金属网和涤纶织物制成，呈双盘状，且可自身扩张。

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.

封堵器如何工作？医师在患者腹股沟处做小切口，通过血管，输送系统将封堵器送至心腔内。待医师确认封堵器已经处于正确位置，封堵器将从输送系统上释放下来，同时自身张开并封堵缺损。封堵器留在体内，输送系统则被撤出。

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.

一旦封堵器释放就位，组织会逐步生长于其上并关闭缺损。封堵器将成为心房壁的一部分。

When is it used? The AMPLATZER® Septal Occluder is intended to close openings between the atria (the two upper chambers of the heart). It can be used to treat patients with certain types of atrial septal defects. The device can also be used to close a passageway intentionally made during a surgical operation called a fenestrated Fontan procedure if the surgeon determines the passageway is no longer necessary. (The fenestrated Fontan procedure is an open-heart surgery in which a surgeon makes a new passageway for blood to travel through the heart. It is used to treat a variety of congenital heart defects.)

何时应用？AMPLATZER缺损封堵器用于修补心房壁上的缺损。其适用于几种不同类型的房间隔缺损。此外，这种装置也可以用于关闭Fontan手术过程中留下的开孔。

What will it accomplish? The implant will permanently close the defect in the heart without open-heart surgery. This may result in a shorter hospital stay and a faster recovery time.

这种装置优点在哪里？封堵器可以在不开胸的情况下永久封堵缺损。这样住院时间和恢复时间都会大为缩短。

When should it not be used? The Amplatzer® Septal Occluder should not be used in patients who:

• have extensive cardiac anomalies and require open-heart surgery;
• have certain types of infections that do not respond to treatment;
• cannot take aspirin or other blood-thinning drugs;
• have blood clots in or near the heart;
• are allergic to nickel.

Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=P000039