MitraClip is backed by more than 16 years of clinical experience with proven safety, survival and durable clinical outcomes. Data presented at PCR e-Course this year from a real-world clinical study of over 1,000 MitraClip patients showed a high implant success rate (99%) and demonstrated MR reduction to the level of none or trace in patients with either primary MR (to ≤1+ in 87.1%) or secondary MR (to ≤1+ in 90.1%) at 30 days. This recent data confirms MitraClip's best-in-class MR reduction to date1 and adds to a body of evidence that demonstrates significant impact for patients, including improved clinical outcomes and quality of life.
"An enduring measure of our mission to help people live better lives through better health is our success in advancing new standards of care for the treatment of structural heart diseases," said Michael Dale, senior vice president of Abbott's structural heart business. "This CE Mark, along with other recent approvals and advancements for our MitraClip device, underscores the need for MitraClip's innovative therapy – which has become a preferred choice for the treatment of mitral regurgitation around the world."
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The MitraClip system has been commercially available in the U.S. since 2013 and in Europe since 2008. Recent regulatory milestones for the device include the first-ever commercial introduction of MitraClip therapy to China and approval in Japan for the fourth generation of MitraClip, both in June of 2020. These milestones are of critical importance for the Asia-Pacific region where many people suffer from MR but may not have had a treatment option available to them. Since its initial approval, more than 100,000 people have been treated with MitraClip in all major regions around the world.
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 107,000 colleagues serve people in more than 160 countries.
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