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Abbott receives U.S. approval of next-generation MitraClip, bringing new enhancements to Abbott's leading MitraClip platform

Press releases may be edited for formatting or style | July 16, 2019 Cardiology


About the MitraClip System
The MitraClip system has been commercially available in the U.S. since 2013 and in Europe since 2008. With more than 15 years of clinical experience and over 80,000 patients treated worldwide, the MitraClip system is the first and only transcatheter mitral valve therapy with proven safety and survival, and durable clinical outcomes.

MitraClip was approved in the U.S. in 2013 for primary MR patients. In March of this year, FDA approved MitraClip for secondary MR patients based on results from the COAPT Trial, which investigated MitraClip for treating secondary MR. A landmark trial, COAPT showed a 47% relative reduction in hospitalizations and a 38% relative reduction in mortality. Both primary and secondary MR patients may benefit from MitraClip therapy based on this expanded indication for MitraClip. Since the initial approval, Abbott has introduced two newer generations, G2, G3 and now G4, to support patient care.

Abbott is the global leader in developing transcatheter mitral valve technologies as alternatives to open-heart surgery. Building upon its success with the MitraClip device and many years of mitral valve experience and clinical evidence, Abbott is also leading the way in novel, transcatheter devices by investing in the development and clinical study of new mitral valve replacement technologies.


About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.


SOURCE Abbott

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