FDA Discloses Truth to Senator Charles Grassley(IA), Regarding the Experimental Device Tested in Patients
Press Conference to be held in Chicago, December 7, 2017 at 12:00 noon at Corvita, 1006 S. Michigan Ave, Suite 500 Chicago, IL 60605
Contact: Nalini M. Rajamannan, 312-498-9496
CHICAGO, Dec. 7, 2017 /Christian Newswire/ -- Dr. Rajamannan's new edition to the Myxo Files reveals confirmation by the FDA to Senator Charles Grassley(IA) that the device, model 5100, is considered experimental and needed an investigational device exemption. Senator Ron Johnson of homeland security is working with the OIG and Congressman Glenn Grothman is working with the FDA on the newly discovered evidence.
The FDA has now determined that the Myxo ETlogix Annuloplasty Ring is not covered under any 510(k) clearance. A significant risk device such as the Myxo ETlogix Annuloplasty Ring that is not cleared or approved would be required to be studied under an investigational device exemption (IDE). Edwards has not yet received 510(k) clearance or IDE approval for Myxo ETlogix Annuloplasty Ring. The sponsor came in for a regulatory meeting with CDRH's OC on October 14, 2008. At this meeting, the sponsor stated that their firm had discontinued distribution of the device. Shortly thereafter Edwards Submitted the 510(K) on October 29, 2008. Edwards also stated publicly in October 2008 that the firm discontinued distribution of the device.
The FDA has confirmed in a news conference in September 2017 that they are relying upon Northwestern University to inform the patients of the experimental nature of the device as the Myxo ETlogix is still classified as experimental.
Edwards Lifesciences received a 510(k) for the Detlogix in April 2009, which is a new device.
FDA Congressional office to Senator Charles Grassley(IA) after three congressional oversight investigations of the FDA, Edwards Lifesciences and the clinical studies related to the device.
Dr. Rajamannan and a patient will be available tomorrow at noon, Corvita on Michigan Ave to review the updated FDA statement and the truth surrounding the devices placed in 667 patients from Chicago and across the United States of America.