Plymouth-based AGA Medical Corporation announced in September the U.S. Food and Drug Administration’s approval of its Amplatzer Muscular Ventricular Septal Defect Occluder for patients with openings between the two lower chambers in the heart, called ventricular septal defects. Most of these openings are congenital heart defects, which occur in two to four out of every 1,000 babies delivered each year.

The Amplatzer Occluder can be used in some patients when surgery is believed to be a high risk based on overall medical or anatomical conditions. The device is a self-expanding double disc made of wire mesh and polyester fabric, and is delivered to the heart via small blood vessels that a doctor accesses through an incision in the groin. Once the device is implanted sandwiching the opening between the discs, heart tissue grows over it and closes the opening—the device becomes part of the wall of the heart. Patients need less time to recover from the implant procedure than they would if they had open heart surgery, the traditional treatment for the condition.