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CoreValve

Transcatheter Aortic Valve Replacement (TAVR) Platform

The CoreValve Transcatheter Aortic Valve Replacement (TAVR) Platform is an approach to treat severe aortic stenosis for those who cannot have open heart surgery.

Transcatheter Valve Delivery

The Medtronic CoreValve Platform can be used to treat patients with unique anatomies and clinical complexities. With a full range of valve sizes, the CoreValve Platform allows heart teams to treat patients with a broad range of annulus diameters. All valve sizes use the same 18 Fr delivery system.

The CoreValve Platform is approved for transfemoral, subclavian, and direct aortic access. These transarterial alternatives are options for patients for whom the ilio-femoral approach is not optimal. The CoreValve device is delivered by catheter, with fluoroscopic guidance, through the body’s cardiovascular system. With step-wise deployment, the Medtronic CoreValve Platform gives implanters the control and adaptability they need.

Patient Selection

Patient with symptomatic severe aortic stenosis and whose doctor has determined that he or she is not a candidate for open heart valve replacement surgery.

Probable Clinical Benefits

Symptom Relief
Most patients receiving a CoreValve heart valve can expect immediate symptom relief. The table below shows the number of patients who showed improvement 30 days and 1 year after their procedure using a standard tool (New York Heart Association heart failure class) to measure how much better they felt.

Access through an artery in your leg (transfemoral)
Pivotal (first 489 patients)		Continued Access (additional 858 patients)
30 Days	1 Year	30 Days
8 out of 10 patients	7 out of 10 patients	8 out of 10 patients

Access through a space between your ribs or an artery in your neck (direct aortic and subclavian)
Pivotal (first 150 patients)		Continued Access (additional 279 patients)
30 Days	1 Year	30 Days
7 out of 10 patients	5 out of 10 patients	7 out of 10 patients

Quality of Life Improvements
The clinical trial assessed quality of life using a combination of standarized tools* to determine the improvement in patients' health after the procedure. These assessments showed substantial improvement in patients’ health 30 days after the procedure and patients continued to experience the improvement at 1 year. Patients reported significant improvements in many quality of life measurements including; reduced pain and anxiety, and increased ability to take care of themselves and participate in everyday activities.

Potential Risks

As with any major medical procedure, there is a risk of complications after the Medtronic CoreValve transcatheter valve implantation procedure.

Death from any cause - death due to any cause, whether heart related or not.
Stroke - a condition when decreased blood flow to the brain causes death of the brain cells, which results in disability.
Major vascular complications - a condition affecting the blood vessels, including blood collecting under the skin (hematoma), or a tear or hole in a blood vessel.
Major bleeding - a bleeding event causing abnormal lab values or requiring blood to be put back into the body.