This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. 

Product Name: MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System
PMA Applicant: Abbott Vascular Inc.
Address: 3200 Lakeside Drive, Santa Clara, CA 95054
Approval Date: March 14, 2019
Approval Letter: Approval Order

What is it? The MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System are two newer models of the MitraClip Clip Delivery System approved previously by the FDA. Each system contains a permanent implant that looks and functions like a clip. The clip is used to grasp the two leaflets of the mitral valve in the heart and clip them together to reduce the backflow of blood (called mitral regurgitation or MR).

The current application expands the system’s indications for use to include secondary (or functional) MR, when MR is caused by a dysfunctional left ventricle, not by degeneration of the mitral valve itself.

How does it work? The MitraClip is inserted using a tube-like device (delivery catheter) through the femoral vein in the leg and guided into the left side of the heart. The clip is then positioned by grasping both leaflets of the mitral valve and left in place. The delivery catheter is removed after delivery of the clip.

When is it used? The MitraClip is intended to treat certain patients with moderate-to-severe or severe secondary MR.

What will it accomplish? The MitraClip will reduce the amount of blood that moves in the wrong direction through the mitral valve. As a result, the patient will have:

• improved heart failure symptoms (for example, shortness of breath and fatigue)
• better quality of life
• fewer hospitalizations
• increased chance of survival

A clinical study compared the results of 302 patients treated with the MitraClip device and continued optimal medical therapy and those of 312 patients treated with continued optimal medical therapy alone. The study showed that the risk of being re-hospitalized for heart failure symptoms was reduced by about 47% in the group treated with the MitraClip. In addition, the risk of death within two years was decreased by about 37%.

When should it not be used? The MitraClip device should not be used with:

• Patients who cannot tolerate blood thinners during and after the procedure
• Patients with active inflammation of the heart (endocarditis)
• Patients with rheumatic mitral valve disease
• Patients with evidence of blood clots in the heart or veins leading to the heart.

Additional information:

• Summary of Safety and Effectiveness Data (SSED)
• Patient Labeling: What You and Your Family Should Know About This Minimally Invasive Procedure
• Physician Labeling: Instructions for Use
• PMA Database Entry