Northwestern University and Major Heart Valve Manufacturer are at the Center of the Myxo Cover-Up

Northwestern University and Major Heart Valve Manufacturer are at the Center of the Myxo Cover-Up PR Newswire CHICAGO, September 25, 2012 CHICAGO, September 25, 2012 /PRNewswire/ -- The Myxo Etiologix model 5100, also known as the Myxo 5100 is a heart valve device manufactured and introduced to the market by Edwards LifeSciences (Irvine CA) in 2007. This device was specifically designed to treat the Myxo disease, an illness that causes a leaky heart valve. Despite being sold and surgically implanted into patients in the US market since 2007, it appears as if the Food and Drug Administration who approves the marketing of all medical devices, was unaware that the Myxo 5100 was on the shelves. In fact, Edwards failed to apply for an investigational device exemption for the Myxo 5100 which is required under FDA law 21 CFR 812.2 in 2006 when the first prototype models were made for human experiments. Northwestern also failed to obtain informed consent from patients which violate the Common Rule 45 CFR 46 which is a requirement in this country. According to the Public Pair Patent website, Edwards LifeSciences applied for a patent on the device from 2004-2007, which included several claims modifying the shape in order to demonstrate a unique invention. Subsequently these changes resulted in new patent awarded by the United States patent office in 2007.