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Use of Unapproved Myxo Ring Questioned by Sen. Grassley

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Allegations that Edwards LifeSciences’ experimental Myxo ETlogix 5100 Ring device was implanted in a patient without her consent has sparked a Congressional probe.

Antonitsa Vlahoulis, who received the device in 2006,  told the Chicago Tribune that she would have never consented to receiving an experimental implant.  She claims officials from Northwestern Memorial Hospital and Edwards told her the device was not experimental because it was a modified version of one of the company’s other repair rings, which are approved by theFood & Drug Administration (FDA).  Vlahoulis later had the Myxo Ring removed because of inflammation, and now needs a heart transplant.

Vlahoulis has since filed a lawsuit, and is seeking more than $50,000 in damages from the surgeon who implanted the device,  Northwestern Memorial Hospital and  Edwards Lifesciences.

Senator Charles Grassley (R-Iowa)  began  investigating the Myxo Ring after hearing from Vlahoulis and her cardiologist. According to Reuters.com, Vlahoulis’ surgeon was Dr Patrick McCarthy, who Grassley said  appears to have invented the device and receives royalty payments from the Edwards Lifescience.

Grassley has sent a letter to at Northwestern University, Northwestern Memorial Healthcare and the FDA seeking to find out if the allegations about the Myxo Ring are true, the Chicago Tribune said.  Grassley’s letter questions assertions that the Myxo Ring was simply a modification of an earlier approved device.  Grassley’s letter said his staff was told by Vlahoulis’ cardiologist that “the Myxo Ring is not a minor modification because, among other things, the shape of the ring is triangular whereas other annuloplasty rings are oblong.”

The Myxo ETlogix 5100 Ring, a device that  repairs faulty heart valves, was first implanted in a patient in March 2006.  The FDA has received 10 reports on adverse events related to the Myxo Ring and an investigation is currently underway to determine whether the agency received proper notice about the device.

According to the Chicago Tribune, Edwards released a statement Wednesday, saying it had now submitted an application seeking FDA approval of the Myxo Ring.  According to Reuters.com, the company has also stopped shipping the device, and has removed it from the company’s website.

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