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  1. Device Approvals, Denials and Clearances

GORE® CARDIOFORM Septal Occluder - P050006/S060

GORE® CARDIOFORM Septal Occluder - P050006/S060

Image of GORE® CARDIOFORM Septal Occluder - P050006/S060

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: GORE® CARDIOFORM Septal Occluder
PMA Applicant: W. L. Gore and Associates, Inc.
Address: 32360 NORTH VALLEY PARKWAY PHOENIX, ARIZONA 85085
Approval Date: March 30, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf5/P050006s060a.pdf

What is it? The GORE CARDIOFORM Septal Occluder is a device that is permanently implanted in the heart to close a patent foramen ovale (PFO). A PFO occurs when the foramen ovale, a naturally occurring hole located between the two upper chambers of the heart (the right atrium and the left atrium), does not close shortly after birth. If untreated, a PFO can allow a small amount of blood to pass from the right side of the heart to the left side of the heart. In rare cases, a PFO may lead to the occurrence of strokes.

The device includes an implant (occluder) and a delivery catheter (a small tube). The occluder is made of self-expanding, nickel-titanium (Nitinol) wires, covered in woven fabric. The occluder is shaped as two discs connected in the center. The occluder is compressed to a small size to allow it to pass through the delivery catheter so that physicians can implant it within the heart.

How does it work? The occluder is implanted in the heart to close/fill the hole of the PFO. To implant the device, a physician first inserts the delivery catheter through a vein in the leg until it reaches the heart. The physician then moves the compressed occluder through the delivery catheter until it is positioned at the PFO. The occluder is uncovered from the end of the delivery catheter so that one disc is located in the right atrium and one disc in the left atrium. When correctly positioned, the occluder blocks blood clots from passing from the right atrium to the left atrium through the PFO. The physician then removes the delivery catheter from the body, and leaves the occluder permanently implanted in the heart. Over time, a thin layer of tissue covers the device.

When is it used? The GORE CARDIOFORM Septal Occluder is intended to be used for adult patients between the ages of 18-60 years old who have had a previous cryptogenic stroke (a stroke with an unidentified cause), who are also taking blood-thinning medications, such as aspirin, to prevent another stroke. In most patients, a PFO causes no medical problems and does not require treatment. However, cryptogenic strokes in patients who also have a PFO may be caused by a blood clot that passed through the PFO.

The GORE CARDIOFORM Septal Occluder should only be used after a neurologist and cardiologist have ruled out other causes of stroke.

A PFO is a common finding in the general population (occurring in one out of three to one out of four individuals). In the vast majority of individuals, a PFO causes no medical problems and does not require treatment. However, a PFO may lead to the occurrence of strokes in a small number of patients.

Most strokes are caused by a blockage in a blood vessel carrying blood to the brain. In most cases, patients who have had strokes will undergo medical tests to identify the cause of the stroke (and receive treatments to prevent another stroke), but in some patients, doctors cannot identify the cause of the stroke. This is called a cryptogenic stroke. When a cryptogenic stroke occurs in a patient who also has a PFO, it is possible the stroke was caused by a blood clot that passed through the PFO.

What will it accomplish? The GORE CARDIOFORM Septal Occluder was evaluated in a clinical study in which the device with blood-thinning medication was compared to blood-thinning medication alone. The results showed that the rate of a new stroke was 77% lower in patients treated with the GORE CARDIOFORM Septal Occluder plus blood-thinning medication compared to blood-thinning medication alone. However, the risks of the GORE CARDIOFORM Septal Occluder include injury to the heart, irregular and/or rapid heart rate, blood clots in the heart, leg or lung, bleeding, and stroke.

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

  • Are unable to take antiplatelet or anticoagulant (blood-thinning) medications such as aspirin, heparin, or warfarin.
  • Have anatomy where the GORE® CARDIOFORM Septal Occluder would interfere with other heart or vessel structures, such as cardiac valves or pulmonary veins.
  • Have active endocarditis (heart infection), or other infections producing bacteremia, or patients with known sepsis (blood infection) within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement.
  • Have known intracardiac thrombi (blood clots in the heart).

Additional information (including warnings, precautions, and adverse events):