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© 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014 Information contained herein intended for use in ITALY ONLY MitraClip.

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Presentation on theme: "© 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014 Information contained herein intended for use in ITALY ONLY MitraClip."— Presentation transcript:

1 © 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014 Information contained herein intended for use in ITALY ONLY MitraClip Therapy Worldwide Experience 2014 August 31, 2014

2 © 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014 2 Information contained herein intended for use in ITALY ONLY *Data as of 8/31/2014. Source: Abbott Vascular StudyPopulationN* EVEREST I (Feasibility)Feasibility patients55 EVEREST II (Pivotal)Pre-randomized patients60 EVEREST II (Pivotal)Non-randomized patients (High Risk Study) 78 EVEREST II (Pivotal)Randomized patients (2:1 Clip to Surgery) 279 184 Clip 95 Surgery REALISM (Continued Access)Non-randomized patients899 Compassionate/Emergency UseNon-randomized patients66 ACCESS Europe Phase INon-randomized patients567 ACCESS Europe Phase IINon-randomized patients286 Commercial UseCommercial patients14,232 Total16,427 +95 surgery Worldwide Experience

3 © 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014 3 Information contained herein intended for use in ITALY ONLY Commercial MitraClip Implant Experience –Treating Centers:397 –Patients 1 :15,085 –Implant Rate 1 :96% –Etiology 2 Functional MR 66% Degenerative MR22% Mixed 12% Data as of 8/31/2014. Source: Abbott Vascular. Etiology 2 1.First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients 2.Etiology not inclusive of U.S. cases as of 04/14/2014

4 © 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014 4 Information contained herein intended for use in ITALY ONLY Global MitraClip Procedures *Data as of 8/31/2014. Sources: Apollo System; Case Observation Forms. This includes all submitted and reviewed procedures, including successful and unsuccessful procedures as reported in Apollo.

5 © 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014 5 Information contained herein intended for use in ITALY ONLY MitraClip Therapy Current Global Adoption Treating Centers411 Patients (clinical and commercial) 16,427 Patients 1 (commercial) 15,085 Implant Rate 1 96% Functional MR66% Degenerative MR 2 22% Mixed12% 1.First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients 2.Etiology not inclusive of U.S. cases as of 04/14/2014

6 © 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014 EVEREST I, EVEREST II, REALISM and ACCESS-EU are Abbott Vascular Sponsored Studies MitraClip is a trademark of the Abbott Group of Companies. Products intended for use by or under the direction of a physician. Prior to use, it is important to read the package insert thoroughly for instructions for use, warnings and potential complications associated with use of this device. Product is subject to prior training requirement as per the Instruction for Use. Information contained herein is for distribution for ITALY ONLY. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force. All drawings are artist’s representations only and should not be considered as an engineering drawing or photograph. Photo(s) on file at Abbott Vascular. For more information, visit our website at abbottvascular.com


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