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November 30, 2016

Medtronic receives CE mark for HVAD Implant Procedure

Medtronic has received CE mark for its HVAD System left ventricular assist device (LVAD) for less-invasive implant procedures in patients with advanced heart failure.

Medtronic has received CE mark for its HVAD System left ventricular assist device (LVAD) for less-invasive implant procedures in patients with advanced heart failure.

The HVAD system uses a smaller incision which reduces surgical bleeding and related blood transfusions, potentially reducing the development of right heart failure consequently minimising the duration of hospital stays.

The thoracotomy implantation technique can keep the area around the heart largely intact and preserve the sternum for future procedures or a heart transplant.

"CE Mark for the thoracotomy procedure is a testament to the HVAD System's flexibility and versatility, and may enable more patients to receive the life-sustaining benefit of the device for the treatment of advanced heart failure."

Medtronic cardiac rhythm and heart failure division medical director and heart failure business vice-president and general manager David Steinhaus said: "The HVAD System is the only full-support, centrifugal LVAD approved in Europe for thoracotomy implantation, providing clinicians with greater freedom to choose the best surgical technique for each patient.

"CE Mark for the thoracotomy procedure is a testament to the HVAD System's flexibility and versatility, and may enable more patients to receive the life-sustaining benefit of the device for the treatment of advanced heart failure."

The HVAD System features the small-sized, full-support, centrifugal circulatory assist device, the HVAD Pump which can be easily implanted through a small, lateral thoracotomy incision between a patient's ribs on the left side of the chest.

Currently the prospective LATERAL clinical trial study of a full-support ventricular assist device (VAD) to evaluate this implant technique is being conducted in Canada and the US, where the implant procedure currently is not approved.

The study involved patients with end-stage heart failure who are not responsive to standard medical management and who are eligible for heart transplantation.

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