MitraClip Clip Delivery System – P100009
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 Clip Delivery System
PMA Applicant: Abbott Vascular
Address: 4045 Campbell Avenue, Menlo Park, CA 94025
Approval Date: October 24, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/p100009a.pdf
What is it? The MitraClip Clip Delivery System (MitraClip CDS) consists of implant catheters and the MitraClip device. The device is a permanent implant that attaches to the mitral valve leaflets. This procedure results in a double opening of the mitral valve allowing greater closure and reduces the leakiness of the valve (mitral regurgitation or MR).
How does it work? The MitraClip device is inserted by a catheter through the femoral vein and guided into the heart. The MitraClip device is positioned by grasping both leaflets of the mitral valve. The MitraClip device is left in place and the delivery catheter is removed.
When is it used? The MitraClip CDS is intended to treat patients with significant symptomatic degenerative mitral regurgitation with MR ≥ 3+ who have too high a risk for surgery.
What will it accomplish? The major clinical benefit of the MitraClip CDS is the reduction of MR to ≤2+ possibly resulting in:
- fewer hospitalizations
- improved quality of life
- reverse left ventricular remodeling
- symptomatic relief
When should it not be used?
The MitraClip CDS is contraindicated in patients with degenerative mitral regurgitation with the following conditions:
- Active inflammation of the heart (endocarditis)
- Rheumatic mitral valve disease
- Blood clots present at the intended site of implant or blood clots in vessels through which access to the defect is gained, and in
- Patients who cannot tolerate blood thinners (anti-coagulation and anti-platelet medications).
Surgery for repair of the mitral valve is the treatment of choice for patients with degenerative mitral valve regurgitation who are candidates for surgery.
The Summary of Safety and Effectiveness Data and labeling are available.