The MitraClip Clip Delivery System (CDS) consists of three major components:
1) the Delivery Catheter
2) the Steerable Sleeve, and
3) the MitraClip Device (Figure 1).
The 16 Fr Clip Delivery System is introduced into the body through a 24 Fr Steerable Guide Catheter which includes a dilator.
The Steerable Guide Catheter and dilator are 510(k) cleared under K083793 on April 27, 2009, K091596 on July 2, 2009, K093866 on January 13, 2010, K100789 on April 21, 2010 and K112239 on August 31, 2011.
The MitraClip Clip Delivery System is used to advance and manipulate the implantable MitraClip Device for proper positioning and placement on the mitral valve leaflets. The MitraClip Device is a single-sized, percutaneously implanted mechanical clip for the reduction of mitral regurgitation.
The MitraClip Device grasps and coapts the mitral valve leaflets resulting in fixed approximation of the mitral leaflets throughout the cardiac cycle. The MitraClip Device is placed without the need for arresting the heart or cardiopulmonary bypass.
The MitraClip Device is fabricated with metal alloys and polyester fabric (Clip cover) that are commonly used in cardiovascular implants. The MitraClip Device arms can be adjusted to any position from fully opened fully inverted and fully closed.
The Grippers can be raised or lowered repeatedly. The key dimensions of the MitraClip Clip Delivery System are listed in Table 1.
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