RESUMO
The Angel Wings Das device (Microvena Corporation, White Bear Lake, MN) is a self-centering, nitinol-polyester prosthesis with two square-shaped disks and a customized delivery catheter. The implantation success rate for atrial septal defects (ASDs) was 92% and 94% in the Phase I and II trials in the United States, and 97% and 100% for patients with patent foramen ovale (PFO). Residual shunts in the Phase II United States trials at 24 hours by transthoracic echocardiography are as follows: For patients with ASDs, 86% have no or less than 1-mm shunts and 14% have 1- to 2-mm shunts. None of the patients had a large residual shunt. Patients with PFOs had no significant residual shunts at 24 hours. There were no device-related deaths, embolization after successful closure, or episodes of infective endocarditis. The device has been modified to have two circular disks. It is retrievable into the delivery catheter and repositionable. The Angel Wings II device is anticipated to enter clinical use in the near future.