WASHINGTON U.S. Sen. Charles Grassley is investigating whether an Edwards Lifesciences Corp heart valve device is being used without proper Food and Drug Administration approval, according to a letter the Iowa Republican released on Wednesday.
A surgeon at Northwestern University's teaching hospital, Northwestern Memorial Hospital in Chicago, may be implanting a version of Edwards' Myxo Ring in patients without the necessary research permission from the FDA or FDA approval, the Republican senator from Iowa said.
"I recently received troubling allegations that Edwards Lifesciences' (Edwards) Myxo ETlogix 5100 Ring (Myxo Ring), an annuloplasty ring used in heart valve repair, has not been approved and/or cleared for marketing by the Food and Drug Administration (FDA)," he wrote.
The surgeon, Dr. Patrick McCarthy, appears to have invented the device and receives royalty payments from the Edwards Lifescience, Grassley wrote in letters sent to the company, the hospital and the FDA.
Edwards said it had suspended shipments of the device and removed it from the company's website.
"Edwards has elected to take several voluntary actions in response to the ongoing discussions with the FDA," the company said in an e-mail, adding it "will be fully responsive to the senator's questions, as we have been with the FDA."
Neither McCarthy nor the FDA could be reached immediately for comment. Northwestern Memorial Hospital spokeswoman Kris Lathan said the hospital was reviewing Grassley's letter.
Grassley requested information, including all correspondence between Edwards Lifesciences and the FDA, by January 5.
Dr. Nalini Rajamannan, a professor at Northwestern University's Feinberg School of Medicine and head of the valve program at the school's Bluhm Cardiovascular Institute, raised the issue, according to the letters.
Rajamannan reported her concerns to the university, which said in September that McCarthy's work was not considered research, Grassley said.
The company told McCarthy in an e-mail that the 5100 version is not much different than other models, but Grassley said it was unclear whether it was in fact different enough to warrant FDA action.
"I cannot judge whether or not the Myxo Ring required FDA approval or clearance; however, Dr. Rajamannan told Committee staff that, in her opinion, 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," he wrote.
(Reporting by Susan Heavey; editing by Leslie Gevirtz)