MINNEAPOLIS (PRWEB) November 21, 2017
In 2017, Congressman Glenn Grothman sent letters to the FDA, followed by questions from Senator Ron Johnson of WI. The Myxo File XXXIV outlines the investigations, the patient outcomes and the responses sent by the FDA to a local network news station regarding the reporting of the testing of the heart valve devices. The FDA confirmed that the hospital reported to the patients the status of the experimental device on recall in January 2009. However, NBC news reported that the letters did not reveal the fact that the device was on recall and experimental at the time of the test surgeries.
After the series of interviews on local radio and NBC, the Office of Inspector General confirmed that they were investigating the sales of the devices across state lines using Medicare and Medicaid dollars for the price of the test surgeries. For years, the Senate Finance and Judiciary Committees investigated the testing of the non-approved Devices in patients during open heart surgery without informed consent. However, key documents surrounding the patients' testing were withheld from the Senate Committee, the FDA, and the patients.
The Myxo File XXXIV released on Amazon.com contain summaries, to try and get help for the innocent unsuspecting patients.
Nalini M. Rajamannan is a US citizen, born in Minnesota. She is a cardiologist at Most Sacred Heart of Jesus Cardiology and Valvular Institute, Sheboygan, WI, and Chicago, IL. Dr. Rajamannan recently published a textbook on Cardiac Valvular Medicine, Molecular Biology of Valvular Heart Disease, and Osteocardiology, Springer Publisher.
She graduated from the University of Notre Dame, South Bend, IN and Mayo Medical School and Mayo Graduate School, Rochester, MN for all of her medical training. She worked as an Academic Cardiologist at Northwestern University Feinberg School of Medicine from 2000-2011. She is the chair of the recently published position statement from the NHLBI, National Institute of Health working group on Calcific Aortic Valve Disease. Dr. Rajamannan has published an International Clinical trial on the effects of statins in slowing the progression of aortic valve disease in the Journal of the American College of Cardiology with her colleagues from Mastosinhos, Portugal, Hospital Pedro Hispano, and a sub-analysis of SEAS trial with her European Investigators of the SEAS trial. She collaborates in Clinical Trials with CorVita and basic research at the Mayo Clinic as a visiting Scientist.
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