- Posted October 16, 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
Honorable Senator Lugar Responding to the concerns of individual Hoosiers in dealing with the federal government remains an important part of my work as a U.S. Senator.
Excerpts from the letter sent by the FDA to the Honorable Senator Richard Lugar in 2009:
Attached is the final response I received regarding my inquiry on your behalf. I hope this reply includes the information that you need.
Thank you for giving me this opportunity to assist you. Responding to the concerns of individual Hoosiers in dealing with the federal government remains an important part of my work as a U.S. Senator. Please let me know if there is anything more I can do.
NOV 0 5 2009
The Honorable Richard G. Lugar
United States Senator
Washington, D.C. 20510-1401
Dear Senator Lugar:
“Thank you for your letter of August 4, 2009, regarding a situation brought to your attention by Dr. Nalini Rajamannan involving the status with the Food and Drug Administration (FDA or the Agency) of the model 5100 McCarthy Myxo dEtlogix Annuloplasty Ring, manufactured by Edwards Lifesiences (Edwards) LLC, for use in heart valve repair. The material you enclosed included a copy of a July 16, 2009, letter FDA had sent to a patient from Illinois, Ms. Atonista Vlahoulis, who had expressed concern about the use of the Myxo valve product by a surgeon who implanted this device in her. Below are responses FDA has made in reply to several follow-up questions the Agency received to the July 16, 2006, letter addressed to Ms. Vlahoulis …..
2. Did the FDA review any data on the patients who already had the device implanted prior to clearance by the FDA for marketing? Ifnot, why not?
Yes, an overview of the clinical experience to date was reviewed in the 51O(k) submission. This included a paper entitled "Initial Clinical Experience with Myxo ETlogix Mitra! Valve Repair Ring," (J Thorac Cardiovasc Surg 2008:1-9) published by McCarthy et al., information from Edwards Lifesciences' in-house registry, and a review of the Center for Devices and Radiologic Health's (CDRH or the Center) Manufacturer and User Facility Device Experience (MAUDE) database.
The McCarthy paper describes a two-surgeon, single-institution experience with 100 Myxo ETlogix (dETlogix) implants for repair of myxomatous mitral regurgitation over 18 months. The authors reported no postoperative mortality, infection, myocardial infarction, or renal failure. There was one reoperation for bleeding and one stroke. Ninety-eight percent of patients showed no residual regurgitation on intraoperative echocardiogram, with a mean transvalvular gradient of 3.0 mmHg. At hospital discharge (average 5.6 days later), 93.9 percent of patients had no regurgitation and 6.1 percent had
Follow-up was reported for an unknown number of patients with a total of 338 echocardiograms over an average time of 6.1 months (range unknown). Mitral regurgitation (MR) of 1+ was found in 18 percent of the Myxo ETlogix patients; it is stated that there was no statistical difference between discharge MR and follow-up MR, and that no patient had MR > 2+. Persistent, obstructive systolic anterior motion was not seen. The safety and effectiveness outcomes reported in this manuscript are similar to what one would expect for mitral valve repair operations involving an annuloplasty ring.
In the 51O(k) the sponsor provided a summary of the data included in their in-house registry. The sponsor reported that a total of 667 units had been distributed with 10 observations. Four were complaints, including two cases of suture pull-out, one case of a systemic rash responding to steroids, and the fourth, a possible cause of "inflammatory response." The sponsor reported that there were six device explants. Four devices were explanted during the procedure, but without report on whether the device was replaced with a different ring or by valve replacement. Details for the remaining two explants were not available.
The Agency also reviewed medical device reports (MDRs) submitted to the MAUDE database during our review of the 51O(k). This database search returned five entries for four events (it appeared that the first two entries were for the same event). Three of the four events occurred on the date of implant for suture pulling through the annulus or for "unknown reasons." The fourth event was patient death and took place approximately six months after implant. The cause of death was not reported.
Regarding our review of Edwards' in-house registry data and the MDRs submitted for the dETlogix device, the Agency felt that the frequency and type of complaints and adverse events reports were consistent with the expected outcomes in this patient population.
After reviewing all of the data described above, the Agency concluded that the clinical
experience with the dETlogix device was similar to legally marketed annuloplasty rings….”
Acting Commissioner for Legislation