MASSDEVICE ON CALL — Senator Chuck Grassley (R-Iowa) reanimated his inquiry into an Illinois university hospital and a surgeon-inventor who used his device there, following reports from an erstwhile whistleblower that claimed she was fired for providing evidence to federal investigators and for challenging the university’s star surgeon.
In a public letter issued to Northwestern University and Northwestern Memorial Hospital, Grassley accused hospital leadership of withholding requested documents related to the use of the Myxo-ETlogix 5100 Ring, used in heart valve repair.
Grassley noted "inadequacies" in the hospital’s previous responses to the inquiry, saying that inventor and cardiac surgeon Dr. Patrick McCarthy "made contradictory statements regarding the similarity of the Myxo Ring to preexisting devices."
The Myxo Ring device won FDA clearance in April 2009 under a new name, now known as the dETlogix Annuloplasty Ring. Grassley got involved following a 2008 report that McCarthy had implanted the device in patients before it was reviewed by the FDA. Grassley queried the FDA, raising concerns about the 510(k) pathway that accepted Myxo Ring for the U.S. market.
"I recently received a report from Dr. Nalini Rajamannan – a former professor and physician at Northwestern University’s Feinberg School of Medicine and co-author of the protocol for the study – alleging that a series of documents that fall squarely within the scope of my December 3, 2008 letter was withheld by the University, without any notice that the documents were being withheld," Grassley wrote. "If other responsive documents were to be withheld, then notice and an explanation of the reasons for withholding them should have been provided."
The requested documents include a series of forms authored and signed by McCarthy and correspondence with the Institutional Review Board. Grassley maintained that he needs the documents in order to ensure that healthcare providers followed the rules in testing the device and getting it to market.
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