CHICAGO, Dec. 18, 2012 /CNW/ - Understanding the regulatory issue
surrounding the FDA 510(k) process may soon be a thing of the past
thanks to a new book called The Myxo File: Part I and Part II just release through Kindle Direct Publishing. "The patients will
understand what happened during their open heart procedure to repair
their heart valve between 2006-2008." says author Nalini Marie
Rajamannan M. D. Sacred Heart Cardiology, Chicago IL.
"With the Myxo File Part I and Part II, the biographical story and the
documents providing the evidence from the FDA, US Patent office and the
United States Securities and Exchange Commission websites will help to
explain the events that happened during the clinical study to test a
new invention in the hearts of her patients during open heart surgery.
"My book will help to educate the patient 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."
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 US SEC
website. The Filings indicate the chronology of disclosures of the
medical device to investors. "With my electronic file, 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: ConcieValve LLC
For further information:
Kindle Direct Publishing: The Myxo File: Part I and Part II.