- Posted October 24, 2013 by
- 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
In 2013 EVIDENCE: MODEL 5100 WAS NOT COMMERCIALLY SOLD IN THE US UNTIL 1-2007, no FDA listing in 08
In 2013 EVIDENCE: MODEL 5100 WAS NOT COMMERCIALLY AVAILABLE ON THE US MARKET UNTIL JANUARY 2007
THEREFORE FROM MARCH 2006- JANUARY 2007 THE SURGICAL IMPLANTS WERE PART OF THE VALIDATION TESTING FOR THE "JTF"
JTF- Justification to File
DHF- Design History File
DMR- Design Master Record
DVH- Device History File
All of these terms refer to the same device manufacturer record as per Mr. John Twohy from Eichorn and Eichorn, Indiana
Defense Trial Counsel of Indiana
From March 2006- January 2007 Model 5100 was an experimental prototype called the McCarthy annuloplasty ring.
January 2007 to October 2008 Model 5100 was the commerically available device that was implanted in 555 total patients until Edwards Lifesciences pulled the device off the market for a volunatary recall for misbranding of the device.
The FDA informed the patient that the device was not cleared in an email communication dated July 2008 see attached.
April 2009 model 5100 was called the D'Etlogix which is still not sold on the US market or listed as commercially available ring on the Edwards Lifesciences website.
Chicago Magazine January 2007
24 techniques and treatments that are reshaping the war on disease—and the doctors and scientists spearheading those innovations
BY DENNIS RODKIN
Breakthrough Medicine 03
Repairing Heart Valves
Loyola University Medical Center, Mamdouh Bakhos
Northwestern Memorial Hospital, Patrick McCarthy and Nalini Rajamannan
The conventional response to a failing heart valve has been surgery to install an artificial replacement—about 100,000 operations a year in the United States. But at Loyola University Medical Center, Mamdouh Bakhos, a cardiothoracic surgeon, is more often opting for repair. “We’re finding that it’s always better if you can save the patient’s own valve,” he says. “When you put in an artificial valve, you have to put the patient on blood thinners, and you have to worry about a foreign [object] being inside the heart.” Repairing the existing valve wipes out both downsides, Bakhos says, and in recent years he and other Loyola heart surgeons have been repairing about 95 percent of the failed mitral (or bicuspid) and tricuspid valves that they encounter, as well as about 30 percent of the faulty aortic valves.
Photograph: Courtesy of Northwestern Memorial Hospital
An integral part of heart valve repair is the ring that a surgeon installs to seal the valve against leakage. Patrick McCarthy, a cardiothoracic surgeon at North-western Memorial Hospital (NMH), has invented three different types of rings, each with a specific use. The first, which has been available for about four years, is the most commonly used ring for repairs associated with the heart’s tricuspid valve. “The vast majority of leaky tricuspid valves are from the same underlying cause, so it only took one ring to solve the majority of problems,” says McCarthy. In use for about two years, the second ring—which McCarthy developed with the French heart surgeon Alain F. Carpentier and David H. Adams of Mount Sinai Medical Center in New York—was designed for patients who develop a leaky mitral valve following a heart attack. McCarthy’s third ring, which should begin arriving in hospitals in January 2007, treats mitral valve prolapse (that is, a failure of the mitral valve to open and close properly).
Carpentier-McCarthy-Adams IMR ETlogix Annuloplasty Ring
“The second and third rings are taking surgeons into a new area—special rings for special circumstances,” says McCarthy. “We are doing a lot of publishing and training so that everyone understands the idea behind two different rings for the same valve. The goal with these rings was to make the surgery more simple, so a lot more people can [undergo repair surgery] instead of replacing the valves.”
Illustration: John Kenzie
By anticipating who might ultimately need valve surgery, Nalini Rajamannan (also at NMH) hopes to drastically delay the need for surgery. After six years of research, she has identified the chemical pathways that send signals to the heart to calcify valve tissue. As a result, she can now help doctors determine which people need to go on intensive cholesterol-fighting programs while still in their 30s or 40s. “We can tell you now that you need to do this—or else,” Rajamannan says. “We can put people on statins [to fight cholesterol] much earlier to work against the risk. If it keeps them out of surgery, that’s not so bad”—so long as doctors continue to monitor their patients for any harmful side effects. “They might live into their 80s or 90s without any valve problems.”
FDA REGULATIONS FOR THE COMMERCIAL SALES OF A MEDICAL DEVICE