Medtronic receives CE Mark approval for new HVAD System procedure

Medtronic has announced that its left ventricular assist device (LVAD) the HVAD System has been approved in Europe for use with a new implant procedure.

The new process is less invasive than the standard technique. It uses a smaller incision, potentially lessens surgical bleeding and related blood transfusion, and can reduce the development of right heart failure and lead to shorter hospital stays.

Additionally, the technique may allow the area around the heart to remain largely intact, potentially preserving the sternum for future procedures or heart transplants.

The device is the only centrifugal LVAD approved in the EU for implantation via this new thoracotomy procedure, and is used in the treatment of advanced heart failure.

Dr David Steinhaus, vice-president and general manager of Medtronic's heart failure business, 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."

The HVAD System originally received CE Mark approval in 2009 and has been used to treat more than 11,000 patients with advanced heart failure to date.

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