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FDA APPROVES TWO NEW MEDICAL DEVICES TO TREAT CONGENITAL HEART DEFECTS

The Food and Drug Administration today approved two devices that may provide an alternative treatment to open heart surgery for patients with two types of congenital heart defects.

The devices, called septal occluders, are implanted in the heart by way of catheters (thin plastic tubes) inserted into either an artery or a vein.

The two types of congenital heart defects are ventricular septal defect, a hole between the bottom chambers of the heart, and atrial septal defect, a hole between the top chambers of the heart. Normally these defects are corrected through open heart surgery.

The products are the Cardioseal Septal Occlusion System, made by NMT Medical, Inc., of Boston, Mass., approved to close complex ventricular septal defects; and the Amplatzer Septal Occluder, made by AGA Medical Corporation, of Golden Valley, Minn., approved to close secundum atrial septal defects, those located in the mid portion of the atrial septum.

The devices are made from either a metal frame or wire mesh and fabric. The design and shape of the products vary, as does the exact mode of deployment.

FDA based its approval of the two products on a review of clinical studies of safety and effectiveness conducted by the manufacturers and on the recommendation of the Circulatory Systems Devices Panel of FDA's Medical Devices Advisory Committee.

FDA is requiring each company to continue to study its product over the next five years to better assess the long-term safety and effectiveness of the devices.

The Cardioseal was already approved for limited marketing under the agency's humanitarian device exemption, a special regulatory clearance that makes devices available for patients with rare medical conditions. Today's action gives NMT Medical approval for more widespread marketing.

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