Senate committee investigating Edwards, Northwestern, and FDA over Myxo annuloplasty ring

Shelley Wood

December 04, 2008

Washington, DC - Sen Charles Grassley (R-IA) has launched an investigation to determine whether Edwards Lifesciences marketed the Myxo-ETlogix mitral-valve ring without first obtaining FDA approval and whether the device was being used without informed patient consent. In letters sent Wednesday to Edwards, Northwestern University, and the FDA, Grassley, the ranking member of the Senate Finance Committee, said he had "recently received troubling allegations that Edwards Lifesciences' Myxo ETlogix 5100 Ring . . . has not been approved and/or cleared for marketing by the Food and Drug Administration."

As previously reported by heart wire , the Myxo ring was invented by Northwestern surgeon Dr Patrick McCarthy. Both McCarthy and Northwestern have been fending off allegations from a patient that McCarthy used the device before it was formally approved and without first telling the patient that he might use it.

From the outset, Edwards, McCarthy, and Northwestern have insisted that the device was commercially available at the time it was used. McCarthy has previously told heart wire that he had been given "no indication from Edwards that [the Myxo ring] is not an FDA-'cleared' product.' " Northwestern, likewise, has stated that an internal investigation by its office for research integrity concluded that the ring was not an investigational device, that proper consent was obtained for its use, that McCarthy had complied with Northwestern's conflict-of-interest disclosure requirements, and that the university "considers this matter closed."

But as heart wire reported in October 2008, another cardiologist at Northwestern, Dr Nalini Rajamannan, has come forward saying she believed the device to be investigational at the time it was used in her patient, Antonitsa Vlahoulis; the FDA has subsequently acknowledged that it is investigating the status of the Myxo valve. Edwards, meanwhile, pulled all information on the Myxo from its website after the heart wire story was published, and a company spokesperson confirmed that it has voluntarily, temporarily suspended any new shipments of the device in the US "and will be collecting product in customer inventory."

Letters demand details of Myxo approval and use

In the letter sent to Edwards, Grassley asked for information regarding if and when Edwards submitted information and/or a 510(k) application to the FDA; when the Myxo ring became commercially available; when it was first implanted; on what grounds the company determined that the device was approved; the number of rings implanted by McCarthy; any correspondence between Edwards, Northwestern, and the FDA regarding the Myxo ring; and any payments made by Edwards to McCarthy or to Northwestern.

In response to the Grassley letter, Edwards provided a statement to heart wire saying that the company "will be fully responsive to the senator's questions, as we have been with the FDA." The statement also notes: "Since early August, Edwards has been working closely and in cooperation with the FDA pertaining to this patient inquiry regarding the Myxo ETlogix annuloplasty ring."

The statement from Edwards also notes that the company had previously interpreted FDA regulatory guidance to mean that the Myxo ETlogix was "neither an investigational nor an experimental device" but stated that on October 27, 2008, the company had voluntarily submitted a 510(k) premarket submission to the FDA for the Myxo ring.

In the letter to FDA commissioner Dr Andrew von Eschenbach, Grassley asked for details on applications or communications from Edwards about the Myxo ring and to explain whether or not implantation of the device "should be conducted under an investigational-device exemption." Grassley also asked for a briefing when the FDA concludes its own investigation. An FDA spokesperson confirmed to heart wire earlier this week that the Myxo investigation is still ongoing.

In the letter sent to Northwestern University President Dr Henry S Bienen and Northwestern Memorial Hospital President/CEO Dean Harrison, Grassley asked for information on the Northwestern's internal investigation of the concerns raised by Vlahoulis about the Myxo ring; copies of all correspondence between the university, the FDA, and Edwards; information provided to the institutional review board about the study Vlahoulis participated in when she received the ring; and any university documentation of McCarthy's outside income and conflicts of interest between January 2004 and June 2008.

Contacted by heart wire , a spokesperson from Northwestern Memorial Hospital said only that the letter was received yesterday and was being "thoroughly reviewed."

Grassley's letter also asks Northwestern to explain actions taken against Rajamannan and specifically why she was asked to agree, in a letter sent July 24, 2008, "not to provide clinical care at Northwestern Medical Faculty Foundation and Northwestern Memorial Hospital."  

Rajamannan has confirmed to heart wire that her clinical practice at Northwestern is "on hold" but that she is still a full faculty member at Northwestern and has continued work on her N ational I nstitutes of Health R01 grant work during the period in question.

Speaking with heart wire , Rajamannan said, "It is clearly important that Sen Grassley's office has taken notice of this issue with the 510(k) approval process. I believe it is important, on behalf of patients who are receiving devices, that the FDA's regulatory process [include] stringent investigation of each device prior to granting full FDA indications and 510(k) approval."

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