Use of MitraClip for mitral valve repair in patients with ...
© 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014...
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Transcript of © 2014 Abbott. All rights reserved. AP2939842-OUS Rev. D (09/2014) 9-IT-8-4778-01 10-2014...
© 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 TherapyWorldwide Experience 2014
August 31, 2014
© 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
Study Population N*
EVEREST I (Feasibility) Feasibility patients 55
EVEREST II (Pivotal) Pre-randomized patients 60
EVEREST II (Pivotal) Non-randomized patients(High Risk Study)
78
EVEREST II (Pivotal) Randomized patients(2:1 Clip to Surgery)
279184 Clip
95 Surgery
REALISM (Continued Access) Non-randomized patients 899
Compassionate/Emergency Use Non-randomized patients 66
ACCESS Europe Phase I Non-randomized patients 567
ACCESS Europe Phase II Non-randomized patients 286
Commercial Use Commercial patients 14,232
Total 16,427+95 surgery
Worldwide Experience
© 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– Patients1: 15,085– Implant Rate1: 96% – Etiology2
• Functional MR 66%• Degenerative MR 22%• Mixed 12%
Data as of 8/31/2014. Source: Abbott Vascular.
FMR 66%
DMR 22%
Mixed 12%
Etiology2
1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients2. Etiology not inclusive of U.S. cases as of 04/14/2014
© 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.
© 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 Centers 411
Patients (clinical and commercial) 16,427
Patients1 (commercial) 15,085
Implant Rate1 96%
Functional MR 66%
Degenerative MR2 22%
Mixed 12%
1. First-time procedures only. Includes commercial patients, ACCESS I and ACCESS II patients2. Etiology not inclusive of U.S. cases as of 04/14/2014
© 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