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Clinical Data Double-Boost Supports Medtronic's HeartWare Investment

Executive Summary

Results of the LATERAL trial presented at the recent ISHLT conference show Medtronic's HVAD can be implanted safely through a thoracotomy procedure instead of the standard sternotomy approach, which is far more invasive. At the same meeting, subset data from the ENDURANCE trial confirms that the sickest heart-failure patients treated with HVAD have similar outcomes as less sick patients, and results of the ENDURANCE Supplement show that blood pressure management minimizes the risk of stroke with HVAD.

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A cost-effectiveness analysis of the LATERAL trial shows patients treated with Medtronic’s HeartWare HVAD through the less-invasive thoracotomy procedure incurred lower hospitalization and medical supply costs than patients implanted with a ventricular assist device through the traditional sternotomy approach. Another new analysis shows HeartWare HVAD is more cost-effective than ventricular assist devices of the past.

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The expanded labeling gives Medtronic's HVAD, acquired when it bought HeartWare last summer, the same indication as Abbott's HeartMate II ventricular assist device.

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