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 and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: GORE HELEX™ SEPTAL OCCLUDER
PMA Applicant: W.L. GORE & ASSOCIATES
Address: 1505 North Fourth Street, Flagstaff, AZ 86003 -3000
Approval Date: August 11, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050006a.pdf
What is it? The HELEX Septal Occluder is a minimally invasive device intended for the closure of an ostium secundum Atrial Septal Defects (ASDs) using cardiac catheterization. The device is made up of two parts, the delivery system and the occluder. The delivery system is a hollow catheter used to move the occluder through blood vessels to the defect in the atrial septum. The occluder is a permanent implant consisting of a circular wire frame covered with a thin GORE-TEX membrane. The wire frame is made of a nickel-titanium alloy called nitinol.
How does it work? An atrial septal defect is an abnormal hole (defect) in the wall (septum) between the heart’s upper chambers (atria). The GORE HELEX Septal Occluder is used to close this hole. The delivery system, which is a flexible, hollow catheter, is inserted into a blood vessel through a small incision (cut), usually on the inner thigh. The catheter is then advanced inside the blood vessel until it reaches the heart. The occluder is passed through the hollow catheter and into the heart where it is placed across the defect, positioned to cover the hole, and then released from the delivery catheter.
When is it used? The HELEX Septal Occluder is used in patients who have an ostium secundum Atrial Septal Defect (ASD) that needs to be closed.
What will it accomplish? Once the device is in place, tissue will grow over the device closing the defect. The device will then become a part of the wall of the heart. Closure of an ASD by cardiac catheterization may include a shortened hospital stay, reduced scarring and an easier, more rapid recovery.
When should it not be used? The GORE HELEX Septal Occluder should not be used in:
- Patients with extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
- Patients unable to take anti-platelet or anticoagulant preventative medications such as aspirin, heparin, or warfarin.
- Anatomy where the GORE HELEX Septal Occluder size or position would interfere with other intracardiac or intravascular structures.
- Active endocarditis or other infections producing bacteremia, or patients with known sepsis within one month of implantation, or any other infection that cannot be treated successfully prior to device placement.
- Patients whose vasculature is inadequate to accommodate a 9 Fr delivery sheath.
- Any patient known to have intracardia thrombi.
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=p050006