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FDA Approves New Heart Device for Heart Surgery

The FDA has approved a new heart device called the Gore Helix Septal Occluder. The new heart device is to help people who have a hole in their heart. “The trick to the device is to have a patch through a small incision in the groin.

A hole in a woman's heart she had since birth. It is common heart defect as many kids are born with this type of condition of having a hole in the heart. Patients born with congenital heart defects are followed throughout their lives by cardiac specialists and later on in life often need heart surgery.

The problem is there is an abnormal hole in the wall between the upper chambers of the heart, causing blood to improperly flow from the left side of the heart to the right, forcing the right side of the heart and lungs to over exert to compensate for the problem.

Using the new device, a doctor creates a patch that fills the hole restoring normal circulation of blood to the heart. This is a new less invasive way compared to traditional open heart surgery.

Some patients can go home the same day with this new way of doing heart surgery.

If left untreated this congenital heart defect can cause the heart to enlarge, or weaken, leaving the patient at risk for serious conditions like pulmonary hypertension, heart failure, or stroke.