Mitral regurgitation (MR) is a very common type of heart valve disease. With this condition, the mitral valve, which is located between the left heart chambers, doesn’t fully close. As a result, blood leaks across the valve. Mitral valve regurgitation can make you feel very tired or short of breath and can affect your quality of life.

Historically, the preferred treatment to restore mitral valve function has been open heart surgery. In most cases, the surgery would involve restoring the valve to its healthy dimensions by implanting a pre-shaped ring. However, some individuals may not be ideal candidates for open-heart surgery. These patients may benefit from a percutaneous mitral valve repair which is designed to address the backward leakage of blood across your mitral valve to help blood flow properly and may be associated with lower procedural and postoperative complications.

The AMEND System is a percutaneous investigational device that is designed to mimic the anatomical reshaping of the mitral valve and clinical results achieved by traditional surgical repair. Unlike other percutaneous mitral repair technologies, the AMEND System is designed to preserve future treatment options if clinically required later.

CAUTION: The Valcare AMEND System is an investigational device. Limited by Federal (U.S.) law to investigational use only. Not available for sale.

The AMEND TS EFS is a prospective, single-arm study to evaluate the AMEND Transseptal System in patients with significant functional mitral regurgitation. The study aims to treat 15 patients and is currently enrolling patients at investigational sites in the United States.

Learn more about the AMEND Early Feasibility Study at ClinicalTrials.gov

Please contact us if you have any questions.

Sources:

• Grave, C. et al., Fourteen-year temporal trends in patients hospitalized for mitral regurgitation: The increasing burden of mitral valve prolapse in men, Journal of Clinical Medicine, 2022
• Nkomo, V.T. et al., Burden of valvular heart diseases: a population-based study. Lancet, 2006
• Rogers, J. et al., Transcatheter annuloplasty for mitral regurgitation with an adjustable semi-rigid complete ring: Initial experience with the Millipede IRIS device, Structural Heart, 2018, 2, No. 1, 43-50
• Ullah, W. et al., Outcomes of open mitral valve replacement versus transcatheter mitral valve repair: Insight from the national inpatient sample database, IJC Heart & Vasculature, 2020 May 28;28:100540