An Atrial Septal Defects (ASD) is a cardiovascular condition characterized by an opening in the heart. The opening is located within the septum, which separates the left and right atria of the heart. An ASD occurs when the opening fails to close after birth, and is associated with low blood oxygen levels. This is a result of de-oxygenated blood passing through the opening and mixing with oxygen rich blood before being pumped out to the rest of the body. One treatment for ASD involves using an Atrial Septal Occluder (ASO), commonly, the “Amplatzer” device, by St. Jude Medical, Inc.. The ASO seals the opening and can be implanted without major surgery. Several cases have been reported involving complications after implantation of an ASO.
Many studies have been conducted to evaluate the effectiveness of ASO implantation, as well as the risk factors involved. One such study was conducted by M Behjati et al. and is titled “Transcatheter closure of atrial septal defect with amplatzer septal occluder in adults: immediate, short, and intermediate-term results,” published in the Journal of Tehran Heart Center in 2011. The authors stated “The transcatheter closure of the atrial septal defect (ASD) has become an alternative technique to surgical procedures. The aim of this study was to assess the immediate, short, and intermediate-term results of the transcatheter closure of the secundum ASD with the Amplatzer Septal Occluder (ASO) in adult Iranian patients.”
The study involved ASO implantation in 58 adult patients. Follow-ups included physical examination, electrocardiography, and transthoracic echocardiography, these were conducted at one month, six months, and annually. Successful deployment of the ASO was observed in 89.6% of patients and failed in the remaining 10.4%. Four patients experienced severe complications. The researchers concluded that ASO’s are associated with a relatively high success rate, but are still subject to complications. The authors stated “The use of this device, however, requires thorough attention in that the procedure may be ineffective or the device may embolize. Further experience and long-term follow-up are required before a widespread clinical use can be recommended.”
Due to the fact that a number of patients have used ASOs unaware of the risk for cardiac erosion associated with Amplatzer devices, a number of Amplatzer ASO lawsuits have been filed against St. Jude, the manufacturer of the Amplatzer. If you or a loved one used an ASO and suffered cardiac erosion as a result, you may be entitled to significant financial compensation.
For more information, or for a free, no-obligation Amplatzer lawsuit consultation, contact our team of Amplatzer lawyers at your convenience. We have the experience, resources, and skills required to win the justice you deserve. Call today and see how we can help!
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Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.