The US Senate Finance Committee is investigating a heart valve made by Edwards Lifesciences and whether the device was implanted in patients by a Northwestern Memorial Hospital surgeon, who invented the device and receives royalties from Edwards, even though FDA approval was lacking.

Apparently, Patrick McCarthy, a cardiothoracic surgeon, allegedly used the Myxo ETlogix 5100 Ring without an Investigational Device Exemption (IDE), which would allow the device to be used in a clinical study to collect data in support of an application to the FDA for approval, according to Chuck Grassley, who is the ranking Republican on the committee.

The allegations were made by Nalini Rajamannan, an associate professor and valve director of the Bluhm Cardiovascular Institute at Northwestern University’s Feinberg School of Medicine, and Antonitsa Vlahoulis, who received the ring during an April 2006 operation, who maintains it was implanted in her without her informed consent or FDA approval, at the time, according to Grassley.

According to a September 18 letter the university sent to Vlahoulis, Northwestern’s Office for Research Integrity completed its own investigation of the allegations and concluded the use of the device was “not research and did not require IRB approval.” The letter also stated Edwards confirmed in an email to Northwestern that the device was commercially available and wrote an e-mail to McCarthy to say the device is a minor modifcation of an earlier model. Rajamannan, however, disputes that contention and claims Northwestern has since “taken action” against her.

Grassley has written Edwards Lifesciences, the hospital and the university for documents and explanations. We will provide links or copies as soon as they become available.