Mitra Clip Mitral Valve Repair System Rachel Mc

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Mitra. Clip Mitral Valve Repair System Rachel Mc. Ateer BME 181

Mitra. Clip Mitral Valve Repair System Rachel Mc. Ateer BME 181

Mitral Regurgitation (MR) o Occurs when the mitral valve fails to close tightly, allowing

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.

Mitra. Clip System

Mitra. Clip System

Chip Delivery System (CDS): Consists of 3 main parts: o Delivery Catheter o Steerable

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

Steerable Guide Catheter (SDC): o Contains a handle made up of knobs and levers,

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.

Results o Approved in more than 40 countries o More than 8, 000 procedures

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

Discussion o High risk of health complications with incorrect positioning o Only approved by

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

References Percutaneous Mitral Valve Repair with the Mitra. Clip Delivery System in High Surgical

References Percutaneous Mitral Valve Repair with the Mitra. Clip Delivery System in High Surgical Risk Patients: Briefing Document for the Circulatory Systems Device Panel Advisory Committee www. fda, gov Mitra. Clip Mitral Valve Repair System < http: //www. abbottvascular. com/int/mitraclip. html> Mitral Valve Regurgitation < http: //www. mayoclinic. com/health/mitral-valveregurgitation/DS 00421/DSECTION=risk%2 Dfactors>