Overview

The Mitraclip® system is used by interventional cardiologists and is intended to reduce mitral regurgitation (MR), adapting the open surgical edge-to-edge technique in a less invasive catheter-based procedure.

Edge-to-Edge Technique

Since the early 1990's, edge-to-edge has been increasingly used in the treatment of mitral regurgitation (MR). Pioneered in Italy by Dr. Ottavio Alfieri, the technique involves suturing together the two leaflets of the mitral valve. The valve continues to open on both sides of the suture, allowing blood flow through the valve from the left atrium to left ventricle, while assuring proper valve closure when blood is pumped from the left ventricle to the rest of the body.

Well over 1,500 procedures have been reported in peer-reviewed clinical literature with up to 15 years of follow-up. The collective experience has demonstrated that the surgical technique appears to be safe, effective and durable.

The Evalve MitraClip system
The system consists of three major subsystems:

A Steerable Guide Catheter,
A Clip Delivery System, and
The MitraClip device(implant).

The Guide Catheter is inserted into the femoral vein at the groin and provides access to the mitral valve. The Clip is used to grasp and fasten together the valve leaflets. The Clip Delivery System is used to deliver and deploy the MitraClip device.
Patients recovering from mitral valve surgery may take up to several months to regain normal physical function and activity. Because the percutaneous MitraClip procedure does not require a chest incision or the use of a heart lung machine, patients may avoid the complications and long recovery time associated with surgery.

Within the United States: Investigational Device. Limited by United States law to investigational use. Within Canada: Investigational Device. To Be Used by Qualified Investigators Only – Instrument de recherche. Réservé uniquement à l'usage de chercheurs compétents.

 This product is available for commercial distribution in the EU.