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ico for Research Inepriy—Nictustam Unvansty 7 Rots if 704 aia She De heats wornoxtwesttneds NORTHWESTERN Pres ssn UNVERSTY foes To: Nalini Rajamannan, MD From: Ann K. Adams AKA\eS Associate Vice President for Research Integrity Date: September 18, 2008 1am writing in response to the concerns you have raised with my office regarding alleged human subject research conducted by Dr. Patrick McCarthy without proper IRB approval and informed consent. Specifically, your concerns centered around Dr. McCarthy's use of the Myxo-ETlogix $100 ring, We appreciate your concems and thank you for bringing them to the attention of this office. After thorough review of your allegations, ‘we have determined that: 1) the Myxo-ETlogix $100 was not an investigational device; and 2) use of patient data from the registry was IRB approved and proper informed consent was obtained. Consequently, contrary to your allegations, there was no human subject research conducted without informed consent or proper approval On August 28, 2007, the device manufacturer, Edwards Lifesciences, confirmed by email that the Myxo-ETTogix 5100 ring was @ minor modification to a preexisting, FDA cleared ting and as such was not an investigational device. In a separate email dated September 10, 2007, Edwards Lifesciences stated that the Myxo-ETlogix 5100 ring has been marketed in the United States since March 2006. The relevant emails are attached. The study you referenced, published by Dr. McCarthy in The Journal of Thoracic and Cardiovascular Surgery in 2008, states that the first use of the Myxo-ETlogix device was March 15, 2006. The article further notes that all data for the publication were obtained through a prospective cardiac surgery outcomes registry. Northwestem’s IRB records indicate that patients undergoing cardiac surgery were consented to allow their clinical data to be used for research purposes through the registry. The consent process for the registry included an IRB-approved informed consent and HIPAA authorization for release of protected health information for research purposes. Because the Myxo-ETlogix 5100 ring was not an investigational device and was ‘commercially available at the relevant time, we have concluded that the use of the device did not constitute human subject research and that Northwestern University was not involved in a clinical trial of the Myxo-ETlogix $100 ring. Moreover, the research published by Dr. McCarthy represented data from subjects properly consented through the IRB-approved prospective registry From: Susan Katz (malito:susan_Katz@edwards.com) ‘Sent: Tuesday, August 28, 2007 4:03 PM Ta: Susan Katz; McCarthy, Patrick M. Subject: RE: Dear Dr. McCarthy- In response to your question - ‘The mode! $100 McCarthy Myxo ETlogix Annuloplasty Ring is not an investigational device, According to the FDA guidance document dated January 10, 1997, Deciding When to Submit a $10(k) for a Change to.an Existing Device, model 100 is 2 minor modification of model 4200, GeoForm Annuloplasty Ring, cleared under K0s2250. ‘The applicable 510k) number for model 5100 is 032250, Let me know if this sufficiently answers your question? Regards, Susan From: Susan Katz [maito:Susan_Katz@edwards.com} ‘Sent: Monday, September 10, 2007 11:11 AM To: Lynch, Julia Ce: Susan Katz ‘Subject: RE: Model $100 McCarthy Myxo Dear julia- It appears you are looking for information about authority to market the product. Tt has been marketed in the US since March 2006 pursuant to the FDA's Siek clearance process. That process does not involve issuance of documentation by the FOA. Please let me know if you have further questions. Regards, ‘Susan Katz Director of Marketing, Mitral Edwards Lifesciences (949) 250-2892