Energy and Commerce Committee Reviews Newly Uncovered Evidence on Citizens Who Received Heart Devices Across the United States From 2006-2008 During…

WASHINGTON, Feb. 13, 2020 /PRNewswire/ -- Dr. Rajamannan, Most Sacred Heart of Jesus Cardiology and Valvular Institute Medical Director, continues the effort to inform the patients of the clinical studies using heart valves invented by surgeons across the United States. The Energy and Commerce House Committee has received the new evidence this week regardingstatements by Northwestern Universitymade in December 2019 to the Illinois Supreme Courtstating that the heart device, the Myxo ETlogix was "FDA approved in 2006," during the clinical study published in the LeadJournal of the American Association of Thoracic Surgeonsin July 2008.

The Energy and Commerce Committeeheld oversight hearingsin August 2009 which included Dr. Marcia Crosse from the Government Accountability Office andDr. WilliamMaiselwho at the time of the hearings, was an Associate Professor of Medicine at Harvard Medical School with more than 15 years of clinical experience as a Boardcertified cardiologist.Dr. Maisel iscurrently the Chief Medical Officerand Director of the Office of Device Evaluation at FDA's Center for Devices and Radiological Health. He is responsible for providing leadership in the development, implementation, execution, management and direction of the Center's broad national and international biomedical science programs. Dr. Maiselconfirmed to the oversight committeethat the device was not approved for use in humans during the study and that the device was placed on recall after the patients received the device without FDA oversight.

Dr. Rajamannan, who has submitted evidence to the Energy and Commerce committee from 2009 to 2020, also presented theFDA Affidavitsummarizing the patients' injuries, as published inThe Daily Northwestern in May 2019.

The New Evidence Provided to the House Committee on Energy and Commerce include:

The Energy and Commerce Committee health committee which has oversight Jurisdiction includes public health and quarantine; public health insurance (Medicare, Medicaid) and private health insurance; medical malpractice and medical malpractice insurance; the regulation of food, drugs, devices, cosmetics, and tobacco (the Food and Drug Administration); drug abuse; the Department of Health and Human Services; the National Institutes of Health; the Centers for Disease Control; Indian Health Service; and all aspects of the above-referenced jurisdiction related to the Department of Homeland Security.

Dr. Nalini Rajamannan is a heart valve expert in the field of cardiovascular medicine. She earned her undergraduate science pre-professional degree from the University of Notre Dame, her Medical Doctorate from Mayo Medical School and her post-graduate training in Internal Medicine and Cardiology at the Mayo Clinic and Research Fellowship on the NIH training Grant. She also worked at the Mayo Clinic as a staff consultant in Internal Medicine and an Associate Professor of Medicine at Northwestern University and the Lakeside and Westside VA. Currently, she practices consultative valvular medicine and Osteocardiology at Most Sacred Heart of Jesus Cardiology and Valvular Institute, WI.

Press Contact Oscar Delgado Press Officer for Most Sacred Heart of Jesus Cardiology and Valvular Institute Former NBC Bureau Chief Latin America 773-573-6890 heartvalves@sacredcardiology.com

Related Files

+Page 5_Testimony_Maisel_Energy_Commerce_2009.pdf

FDAAffidavit_ Investigation MPLS_FDA and Testimony from the Victims_12-19-2018+JMJ.pdf

Related Images

dr-rajamannan-presenting-evidence.jpg Dr. Rajamannan presenting evidence to Congress in Washington DC Presenting evidence to the Energy and Commerce Committee and Senate Finance Committee

dr-rajamannan.jpg Dr. Rajamannan

Energy and Commerce Committee Reviews Newly Uncovered Evidence on Citizens Who Received Heart Devices Across the United States From 2006-2008 During…

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