Edwards Lifesciences shares closed down more than 2% yesterday after the British Medical Journal said many procedures using its Sapien heart valve "cannot be justified on medical or cost-effectiveness grounds."
UPDATED August 1, 2012 with comments from Edwards Lifesciences re. Dr. Martin Leon
Shares of Edwards Lifesciences (NYSE:EW) slid 2.2% yesterday after an analysis published in the British Medical Journal claimed that "many" of the heart valve replacements using its flagship Sapien heart valve "cannot be justified" and leveled accusations of conflict of interest and unethical conduct against Edwards and Sapien inventor Dr. Martin Leon.
A trio of Belgian researchers said their "rigorous analysis of all the available data, in combination with a study of real world [transcatheter aortic valve implant] practice in Europe, led us to conclude that the arguments supporting the widespread use of TAVI do not stand up to scrutiny."
"In addition, the Partner trial seems to have important problems, the most relevant being publication bias and lack of data transparency, unbalanced patient characteristics, and incompletely declared conflicts of interest," wrote Hans Van Brabandt, Mattias Neyt and Frank Hulstaert, who were commissioned by the Belgian government to run the analysis.