- Posted October 15, 2013 by
This iReport is part of an assignment:
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
Government Shut Down Delays FDA Response for Investigational Prototypes: FDA letter on POGO
The First Report of this Experimental Prototype was reported and the letter published by POGO:
Doctors Experimenting on Humans: Five Questions with Dr. Nalini Rajamannan
By PAUL THACKER and BRYAN RAHIJA (Permission given by POGO)
"Dear Ms. Vlahoulis:
Thank you for your inquiry to then-Senator Barack Obama in October 2008, concerning the status with the Food and Drug Administration (FDA or the Agency) of the model 5100 McCarthy Myxo ETlogix Annuloplasty Ring for use in heart valve repair, manufactured by Edwards Lifesciences LLC (Edwards). You also made a similar inquiry with Senator Durbin of Illinois. Both inquiries asked the Agency to look into your situation. Since then-Senator Obama's Senate Office is no longer functioning, we are responding to his inquiry by sending our response directly to you. You will no doubt be hearing from Senator Durbin 's Office independently in the near future. Below we have repeated the two main questions highlighted in those inquiries, followed by the Agency's responses . At the end of the response to question 1, we also include the current status of activity at the Agency concerning this product.
1. Was the Myxo ETlogix Annuloplasty ring 5100 approved by the FDA at the time of surgery?
In a letter dated August 15, 2008, Edwards notified the Agency that they were marketing the Myxo ETlogix Annuloplasty Ring. The letter stated their belief that the Myxo ETlogix was substantially equivalent to the Edwards GeoForm, Model 4200, and Carpentier-Edwards Physio, Model 4450, Annuloplasty Rings, and that the Myxo Ring represented only a minor modification to the pred icate rings.
FDA has determined that the Myxo ETlogix Annuloplasty Ring was not originally covered under any prem rket notification 51O(k) clearance. A significant risk device such as the Myxo ETlogix Annuloplasty Ring that is not cleared or approved would be required to be studied under an investigational dev ice exemption (IDE). On October 14, 2008, the sponsor came in to FDA for a regulatory meeting with the Office of Compliance of the Agency's Center for Devices and Radiological Health. At this meeting, the sponsor stated that the firm had discontinued distribution of the device. Edwards also stated publicly in October 2008 that the firm had discontinued distribution of the device.
On October 29, 2008, FDA received a 51O(k) premarket notification submission from Edwards notifying the Agency of their intent to market the dETlogix (formerly called the Myxo ETlogix) Annuloplasty Ring . On April 10, 2009, FDA cleared a 5 lO(k) for
dETlogix Annuloplasty Ring. The dETlogix Annuloplasty Ring is indicated for the correction of mitral valvular insufficiency where the lesions are not severe enough to require total valve replacement. Clearance of this 510(k) submission demonstrates that the dETlogix device is substantially equivalent to the following legally marketed predicate devices : Edwards GeoForm, Model 4200; Carpentier-Edwards Physic, Model 4450; and Edwards Classic, Model 4400...."
Acting Assistant Commissioner
FDA Legislative Office