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JAMA. 2002;287:578.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA has approved two transcatheter cardiac occlusion devices that offer an alternative to surgery to treat congenital heart defects. One of the devices, CardioSeal Septal Occlusion System with QwikLoad (NMT Medical Inc, Boston), is indicated for use in patients with complex ventricular septal defects (VSDs) that warrant closure and who are considered at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions or overall medical condition.

The device was approved on the basis of a multicenter, prospective, nonrandomized trial with mostly pediatric patients with a variety of hemodynamically significant defects. At the time the VSD data were analyzed, 44 (77%) of the 57 patients with implants had preimplantation and 6-month follow-up data that could be assessed according to the Clinical Status Scale by Lesion (the primary efficacy outcome). The median change in scale value was an increase of two categories (P<.001 compared with . . . [Full Text of this Article]