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Medtronic passes EU approval to market the smaller less-Invasive HVAD Implant in advanced heart failure patients.

M2 EQUITYBITES-November 30, 2016-Medtronic passes EU approval to market the smaller less-Invasive HVAD Implant in advanced heart failure patients

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Medical technology company Medtronic plc (NYSE:MDT) reported on Tuesday the receipt of the CE (Conformite Europeenne) Mark for HVAD System left ventricular assist device (LVAD) technique for a less-invasive implant procedure in patients with advanced heart failure.

In the EU, the company's HVAD System is the only centrifugal LVAD approved for implantation via this new thoracotomy procedure.

The company said the new HVAD Implant uses a smaller incision, lessens surgical bleeding and related blood transfusions, reduces the development of right heart failure and may result in shorter hospital stays.The technique may allow the area around the heart to remain largely intact, preserving the sternum for future heart transplant.

In conjunction, the LATERAL Study is the largest prospective clinical trial of a full-support ventricular assist device (VAD) to evaluate this implant technique. The study includes patients with end-stage heart failure who have not responded to standard medical management and who are eligible for heart transplantation.

According to the company, the HVAD System features the world`s smallest, full-support centrifugal circulatory assist device, the HVAD Pump, which is designed to be implanted next to the heart in the pericardial space. Today, more than 11,000 patients with advanced heart failure have received the HVAD System.

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