Life Sciences

Senator investigating use of unapproved device

Device Regulation Alert: Safety, Compliance and Reimbursement News, December 8, 2008

Senator Charles Grassley (R-IA) wants to know if a Northwestern University teaching hospital surgeon implanted a heart valve in patients without an Investigational Device Exemption, according to a Reuters article.

Cardiothoracic surgeon Patrick McCarthy allegedly implanted Edwards Lifesciences’ Myxo ETlogix 5100 Ring without the device being cleared or approved by the FDA. McCarthy helped invent the device, and receives royalty payments from Edwards Lifesciences.

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, made the allegations against McCarthy.

Grassley sent letters to Edwards Lifesciences, Northwestern Memorial Hospital, and Northwestern University asking for documents and an explaination.

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