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Atrial Septal Defect (ASD) - is a hole in the wall of the upper
two chambers of the heart. Most people who have this type of heart
defect are born with it.
The CardioSEAL and STARFlex devices can, in many cases, be used to treat
this type of heart defect, and are currently available through the
following clinical research trials:
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Ventricular Septal Defect (VSD) - is a hole or may be
multiple holes in the wall between the lower chambers of the heart.
Many of these types of holes are difficult to correct with surgery.
The CardioSEAL and STARFlex devices can, in many cases, be used to
treat this type of heart defect. The CardioSEAL device has been
approved for use in this defect under the
Humanitarian Use Guidelines by the Food & Drug Administration (FDA). A patient
may not need to be enrolled in a clinical trial to receive the
CardioSEAL device for this defect. Individual hospitals need
to get approval from their own review boards and be trained in the
use of the device prior to using it.
The STARFlex device is only available through the
High Risk Trial.
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Fontan Fenestration (FenFon) - The Fontan procedure is
the final surgical step in a series of operations for patients with
Hypoplastic Left Heart Syndrome. There are other defects that may also
have a Fontan procedure. Many times the surgeons leave a surgically
created hole (fenestration) in the repaired section of the heart, which
may improve recovery from the surgery. The fenestration is intended
to be closed at a later time.
The CardioSEAL and STARFlex devices can, in many cases, be used to close
a fenestration. The CardioSEAL device has been approved for this
use under the Humanitarian Use Guidelines
by the Food and Drug Administration (FDA). A patient may not need
to be enrolled in a clinical trial to receive the CardioSEAL device for
fenestration closure. Individual hospitals need to get approval
from their own review boards and be trained in the use of the device prior to using it.
Patients with more than one Fontan fenestration defect or who have other
types of defects may not qualify for the Humanitarian Use
device and may need to be enrolled in the High Risk Trial.
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Patent Foramen Ovale (PFO) - is a hole in the wall
between the upper two chambers of the heart that is present at birth,
but which typically closes soon after.
The CardioSEAL device has been approved under the
Humanitarian Use Guidelines by the Food and Drug Administration
(FDA) for PFO patients who have had a stroke while taking blood
thinners. A patient may not need to be enrolled in a clinical
trial to receive the CardioSEAL device under these circumstances.
Individual hospitals need to get approval from their own review boards
and be trained in the use of the device prior to using it.
The STARFlex devices can also be used to treat this type of heart defect,
and are currently available only through the following clinical research
trials:
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Other heart defects - The CardioSEAL and STARFlex
devices are often used to close less common types of holes in the
heart. For example, some patients who receive a
replacement valve may experience a "leak" that can be closed with a
device. Other types of defects include: leaks resulting
from previous heart surgeries, vascular malformations, patent ductus
arteriosus, and MPA leak.
The CardioSEAL and STARFlex devices can, in many cases, be
used to treat these types of heart defects and are currently available
only through the High Risk Trial.
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