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www.fdanews.com/articles/187661-medtronics-less-invasive-implant-approach-for-heartware-device-gains-approval
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Medtronic’s Less-Invasive Implant Approach for HeartWare Device Gains Approval

July 18, 2018

The FDA approved Medtronic’s less-invasive implant approach for its HeartWare left ventricular assist device used to treat patients with advanced heart failure.

The device helps increase blood flow throughout the body by helping the heart to pump. It is typically implanted via a surgical procedure, median sternotomy, in which a vertical incision is made down the chest and the breastbone is divided.

The new approval allows implantation via thoracotomy, a procedure that makes a small incision between the patient’s ribs on the left side of the chest.

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