| Over the last 20 years significant research has been performed
to design devices to close septal defects without the need for
open heart surgery. These devices are passed through catheters
advanced from the blood vessels that run in the groin.
Device Closure of Atrial Septal Defects
In September 2001, the FDA approved the first
ever intra-cardiac device to close the most common type of atrial
septal defect, the
secundum atrial septal defect. This device is manufactured by AGA
Medical and is known as the Amplatzer® Septal Occluder Device.
The device is made of Nitinol (a nickel and titanium alloy), and
consists of two discs with a connecting waist. The waist plugs
the hole or defect and the discs provide support and hold the connecting
waist in position. This device implant has proved to be very effective
and safe method of closing ASDs. For more information go to www.amplatzer.com.
The other devices, which are still under investigation,
available to close secundum atrial septal defects are the HelexÒ Septal
Occluder manufactured by W.L. Gore (www.goremedical.com/products/HELEX/index.htm)
and the STARFlex or CardioSEAL Septal Occluder (www.nmtmedical.com)
which is manufactured by NMT Medical.
The Pediatric Cardiac Center at Children’s
Hospital and Research Center at Oakland has been involved from
the onset of
clinical trials with the Amplatzer and the Helex devices and has
performed many device closures of secundum atrial septal defects.
Drs. Saba and Patel perform these procedures and would be happy
to provide additional information about these devices.
Device Closure of Ventricular Septal Defects
The CardioSEAL Septal Occluder has been commercially
approved in the USA by the FDA for limited indications using
a FDA approval
process called Humanitarian Device Exemption in types of ventricular
septal defects under its humanitarian use exemption. The indications
for ventricular septal defect device
closure are very specific and if you or your child has a defect
suitable for device closure, this option will be discussed with
you. AGA medical is also researching two VSD devices, which are
currently undergoing clinical studies and it is hoped that the
Children’s Hospital and Research Center at Oakland will be
a study site.
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