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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2009 – Saftey of Amplatzer ASO evaluated

Posted in Atrial Septal Occluders

An Atrial Septal Defect (ASD) is a birth defect of the heart characterized by an opening between the left and right atria that failed to close after birth.  People suffering from an ASD typically have low blood oxygen levels, due to deoxygenated blood passing through the opening in the heart and mixing with oxygen rich blood before being pumped to the rest of the body.  An ASD may be treated with the implantation of an “Amplatzer” Atrial Septal Occluder (ASO).  Implanting an ASO is a fairly simple procedure, and doesn’t require major surgery.  On rare instances, ASOs may erosion and/or change shape.  These changes can cause severe complications, which may be fatal if not treated promptly.

Many studies have set out to explore the factors leading up to these complications, hoping to reduce future complications.  A 2009 study titled “The influence of morphological changes in amplatzer device on the atrial and aortic walls following transcatheter closure of atrial septal defects,” was conducted by Kitano et al. and published in the Journal of Interventional Cardiology in 2009.  The purpose of the study was to analyze physical changes in the ASO after implantation and investigate how they affect the surrounding tissues.  The authors stated “This study prospectively investigated morphological changes in Amplatzer Septal Occluder (ASO) over time and the influences of these changes on the atrial and aortic walls after atrial septal defect (ASD) closure.”

The study included 78 patients with ASD, who had been treated with an ASO.  Any changes in the shape, thickness, and relations to the atrial or aortic walls were evaluated at different points in time.

The researchers documented decreases in the ASO thickness, changes in the ASO’s location and shape.  The author’s stated “As the device becomes thinner, loses its flexibility, and often changes from a flare-to-closed shape on the aortic side over time, the edges of ASO can start to compress the atrial and aortic walls. However, erosion was not recognized in these cases.”

Because ASOs have been found to fail and/or erode in many patients, as documented by a number of research studies, Amplatzer ASO lawsuits are being filed across the country.  If you or a loved one used an amplatzer (especially one manufactured by St. Jude), you may be entitled to significant financial compensation through an amplatzer ASO lawsuit.  For more information, feel free to contact our team of ASO lawyers at your convenience

(855) 452 – 5529

justinian@dangerousdrugs.us

We have the skills, resources, and experience required to win the justice you deserve.  Call today and see how we can help!  Our Amplatzer ASO Lawsuit Information page is a great place to start if you have any questions about ASOs.