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Medtronic reports clinical data showing benefits of HVAD System
Medtronic has announced new clinical trial data that has demonstrated the benefits its HVAD system can offer for people with end-stage heart failure.
Preliminary results from the HVAD LATERAL study have shown that the mechanical pumping system provides positive results for patients with end-stage heart failure who have not responded to standard medical management and are eligible for heart transplantation.
They received the HVAD System through a less-invasive thoracotomy procedure, with results showing that at six months, 87.6 percent of patients remained alive on the original device and free from disabling stroke, or alternatively had received a heart transplant or were explanted due to recovery.
Since the percentage of patients exceeded the pre-specified performance goal of 77.5 percent, it meant the trial was able to successfully meet its primary endpoint.
Dr David Steinhaus, vice-president and general manager of the heart failure business at Medtronic, said: "This innovative technique was pioneered by clinicians whose contributions have helped to significantly advance the field of mechanical circulatory support. The data presented today support this less invasive surgical approach."
The HVAD System is the only full-support centrifugal left ventricular assist device approved for implantation via thoracotomy in the EU.
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