CHICAGO, Jan. 29, 2013 /PRNewswire/ --The Myxo File: Part III, Published January 24, 2013, just released through Kindle Direct Publishing, will provide documents from the FDA, SEC and the U.S. patent office action to further understand the issues that go into heart device manufacturing and safety issues in U.S. patients. A providential meeting with the President of the United States on his birthday in Chicago, with the author and her mother, will turn the events for the patients going to open-heart surgery in the U.S.A. forever.
"The patients need to understand this process and the Myxo File Part III provides a step-by-step chart for a patient to ask the important questions prior to going for open heart surgery," says author Nalini Marie Rajamannan M.D. of Sacred Heart Cardiology, Chicago IL.
"My book will help to educate the citizens of the United States of America and globally to ask the important questions prior to open heart surgery as to whether the device that will be used to repair their valve is FDA registered, cleared, approved, investigational or none of the above," says Dr. Rajamannan.
Rajamannan was inspired to create the Myxo File when the documents she accumulated over a five-year quest to get the information regarding the patients ended with a search of the U.S. SEC website. The filings indicate the chronology of disclosures of the medical device to investors. "With my electronic file and 3-Agency Chart, you still have to take action, and ask your physicians whether you are about to be included in a clinical study to test devices prior to FDA clearance, but at least the citizens of the United States will have a guidepost to help them ask the right questions.
Nalini M. Rajamannan is a cardiologist at Sacred Heart Cardiology, Sheboygan, WI, and Chicago, IL. She is the CEO of ConcieValve LLC, and recently published her textbook on Cardiac Valvular Medicine, 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 is the chair of the recently published position statement from the NHLBI, NIH 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 Spain and Portugal.
SOURCE Nalini Rajamannan, MD