1. MitraClip Mitral Valve Repair System Rachel McAteer BME 181

2. Mitral Regurgitation (MR) o Occurs when the mitral valve fails to close tightly, allowing blood to flow backwards into the heart. o Severity scale of 1+ (mild) to 4+ (severe) o Two kinds: o Degenerative MR (DMR) - includes stretching or rupture of the chordae tendineae. o Funtional MR (FMR) - normal valve anatomy; impaired ventricular wall function and dilation.

4. MitraClip System

5. Chip Delivery System (CDS): Consists of 3 main parts: o Delivery Catheter o Steerable Sleeve o MitraClip Device * The Delivery Catheter and Steerable Sleeve plant the device

6. Steerable Guide Catheter (SDC): o Contains a handle made up of knobs and levers, which control the system, and is attached to a dilator. o Positions the CDS into the appropriate location.

8. Results o Approved in more than 40 countries o More than 8,000 procedures worldwide o More than 1,200 patients treated in the US: o 900 completed minimum 1-year follow up o 96% implant success rate o In 86%, MR reduced to 2+ or less; in many cases 1+ or less o 30-day mortality rate decreased to 4.8% vs. 18.2% usually expected with surgery

9. Discussion o High risk of health complications with incorrect positioning o Only approved by the FDA’s Circulatory System Devices Advisory Panel

10. References Percutaneous Mitral Valve Repair with the MitraClip Delivery System in High Surgical Risk Patients: Briefing Document for the Circulatory Systems Device Panel Advisory Committee www.fda,govwww.fda,gov MitraClip Mitral Valve Repair System http://www.abbottvascular.com/int/mitraclip.html Mitral Valve Regurgitation