- Posted October 6, 2013 by
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Shutdown over: What next?
- MORGAN LEWIS RESPONSE TO THE SENATE FINANCE COMMITTEE CONFIRMING THE FACT THAT THE OUTCOMES REGISTRY HAD NOTHING TO DO WITH THE MYXO ETLOGIX CLINICAL TRIAL
- 150 years later, newspaper retracts editorial panning Gettysburg Address
- OHRP FDA REGULATIONS FOR INFORMED CONSENT CLASSIFIES INVESTIGATIONAL DEVICES SUCH AS THE MYXO ETLOGIX MODEL 5100 UNDER THE LAWS WHICH REQUIRE FULL INFORMED CONSENT:
- FDA CONGRESSIONAL OFFICE ON JULY 16, 2009 OFFICIALLY CATAGORIZES THE MYXO ETLOGIX MODEL 5100, MANUFACTURED BY EDWARDS LIFESCIENCES AS INVESTIGATIONAL AND OF SIGNIFICANT RISK
- Northwestern University and Northwestern Memorial Hospital Elements of Informed Consent : HIPPA WAIVER DOES NOT APPLY TO FDA STUDIES subject to the FDA regulations at 21 CFR 50
Questions raised about Northwestern use of valve device; prominent surgeon denies wrongdoing
Shelley Wood, Oct 2008
"Chicago, IL - Northwestern University is fending off criticism that one of its star surgeons, Dr Patrick M McCarthy, used a device he invented before it was formally approved by the FDA, without first telling patients he might use it. The university, the manufacturer, and McCarthy himself all insist that the device, known as the Myxo ETlogix annuloplasty ring 5100, was commercially available at the time. But heart wire has confirmed that the FDA is investigating the circumstances surrounding its use, and another cardiologist at Northwestern has come forward saying she believed the device to be investigational at the time it was used. One of the patients who received the device is suing McCarthy and Edwards Lifesciences, the manufacturer of the ring.
Myxo ETlogix annuloplasty ring 5100 (Source: Edwards Lifesciences)
Antonitsa Vlahoulis was treated for atrial fibrillation and mitral regurgitation at Northwestern Memorial Hospital in April 2006; McCarthy, widely regarded as one of the top valve surgeons in the US, performed the combined operation. Shortly afterward, Vlahoulis, who shared her medical history with heart wire , developed an intense, generalized, inflammatory reaction involving both mitral leaflets, followed by pericarditis and pericardial effusion requiring pigtail catheter drainage. Vlahoulis ultimately required reoperative mitral-valve surgery for mitral stenosis and a redo Maze procedure. Two years postprocedure, she now has NYHA class 2 heart failure, needs a permanent pacemaker, and is heading to the Mayo Clinic in two weeks for a formal heart-transplant evaluation.
Vlahoulis says she feared that the problems following her first surgery were out of the ordinary but became truly concerned when she received a warranty card from the manufacturer for the device she received during that operation.
The warranty card from Edwards gave the name for the ring she'd received in her first surgery as the McCarthy Annuloplasty Ring 5100, noting her surgeon as the inventor. But according to Vlahoulis, she was never once informed by McCarthy or anyone else at Northwestern that the procedure might entail getting a device that McCarthy had invented and for which he is paid royalties. Her concerns redoubled when a search of the Edwards website turned up no such device per se, but rather a device named the Myxo ETlogix annuloplasty ring 5100—the same number as the "McCarthy" device on her warranty card. The discrepancy, Vlahoulis believes, points to the fact that the device she received was not actually an FDA-approved device, but rather a prototype for the device now dubbed the Myxo ETlogix.
Asked about the discrepancy, an Edwards spokesperson told heart wire that the official name of the device is and always has been the Myxo ETlogix annuloplasty ring.
McCarthy is codirector of the Bluhm Cardiovascular Institute, chief of the division of cardiothoracic surgery at Northwestern, and a big-ticket surgeon at Northwestern—performing roughly 400 surgeries per year, many of them mitral-valve repairs, a procedure that has earned him international renown. He is also a consultant for Edwards. Contacted by heart wire , McCarthy acknowledged that he does receive royalties for the Myxo ring but asserts he donates them to the Greater Chicago Food Depository. He also insists he has "tried and failed" to get Northwestern to agree on language for some type of document he could give patients prior to their surgeries so that they can understand that he is the inventor but doesn't keep royalties for the rings implanted by him or by anyone else at Northwestern.
"I do not know which device I will use until during the surgery, when I've repaired the valve," he explained to heart wire . "I have a range of products available—none are experimental or investigational—and, of course, only choose the device best suited to the patient whether I invented it or not."
He continued, "When I've verbally told patients this in the past, in the context of a discussion of all the various risks and aspects of heart surgery, the range of emotions has varied from perplexed looks to outright laughter. With very rare exception, patients accept that I will do whatever I perceive to be in their best interest."
McCarthy, Edwards, Northwestern: "Device is approved"
The issue of whether the ring Vlahoulis received is approved or not is a closed case for McCarthy, Edwards, and Northwestern, all of whom insist that the device was commercially available as of March 2006—one month before Vlahoulis received it. In a statement to heart wire , an Edwards spokesperson insisted that the Myxo ETlogix was neither an investigational nor an experimental device during the time period in question. "It represents a modification to an existing Edwards annuloplasty ring that was cleared through the FDA's 510(k) process as a Class II device. The modification was analyzed, relying on the FDA's guidance document 'Deciding when to submit a 510(k) for a change to an existing device' (January 10, 1997), and the conclusion was made that a separate 510(k) premarket notification was not required for the device."
That statement, however, seems at odds with multiple documents on the Edwards website, including an investor fact sheet from 2007, a February 2007 conference-call transcript, and the 2007 Annual Report, all of which refer to the Myxo ETlogix as one of the products introduced in 2007. The Edwards spokesperson explained this by saying that the "first commercial implant" of the Myxo ring took place in March 2006, but the "full marketing launch" actually took place at the Society of Thoracic Surgeons (STS) annual meeting in January 2007.
Likewise, the Office for Research Integrity at Northwestern, which has conducted its own investigation into the concerns being raised by Vlahoulis, has concluded that the Myxo ETlogix 5100 was "not an investigational device" and "considers the matter closed."
But the Myxo ring does not come up in a search of the FDA's Medical Device Listing, a mandatory list of devices commercialized by companies, regardless of what class of device they fall into. Contacted by heart wire , the FDA refused to conclusively state that the Myxo ETlogix was, indeed, cleared for commercial use before it was used in Vlahoulis. William C MacFarland in the FDA's Office of Compliance acknowledged that this was in fact a "matter under investigation."
A spokesperson for the FDA Center for Devices and Radiological Health, Peper Long, elaborated to heart wire that the investigation is looking into the company's claim that the Myxo entails only minor product adjustments that would not necessarily require a 510(k) submission. "This particular device is not on our cleared/approved database, but just because it's not, we can't infer that it's being marketed illegally. . . . Submitting a 510(k) is not the only means to market a device, and there are devices on the market that have slight modifications to those cleared devices that don't have to submit a new 510(k)."
Long further clarified that "if a medical device is not approved or cleared by the FDA, in most instances a doctor would need an investigational device exemption [IDE] or be part of a clinical study to use it." In the case of Vlahoulis, the Myxo ring was not used under an IDE.
New experience, but not a new study
Dr Nalini Rajamannan is Vlahoulis's referring cardiologist; she is also valve director for the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital. She told heart wire that she believed in 2006 that Vlahoulis had, indeed, been part of a study of McCarthy's newest mitral-valve ring and assumed that her patient had signed the appropriate consent forms agreeing to be part of the Myxo study. "
Photo from Obermeier v. Edwards, et al., File No. 590.11478 - Dr. Rajamannan deposition
Permission to post the story from theheart.org.