Device that repairs faulty heart valves has problems. Edwards Lifesciences’ experimental Myxo ETlogix 5100 Ring device is at the center of an investigation being conducted by Sen. Charles Grassley (R-Iowa). The Senator is concerned that the Myxo Ring is being used in patients even though it has not yet been approved by the Food & Drug Administration (FDA).
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.
Grassley began his investigation after hearing from Antonitsa Vlahoulis
Grassley began his investigation after hearing from Antonitsa Vlahoulis, an Illinois heart patient, and her cardiologist who said Vlahoulis was implanted with the unapproved device without her consent.
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.
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 the 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 McCarthy, Northwestern Memorial Hospital and Edwards Lifesciences.
Application seeking FDA approval of the Myxo Ring
According to the 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.
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 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.”