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USFDA approval given to Medtronic’s less invasive approach to implant LVAD

Medtronic is a global medical device company based in Dublin, Ireland providing medical technology, services and solutions. The company has received USFDA approval for its less invasive implantation procedure of the left ventricular assist device (LVAD) called HeartWare HVAD system. This will be helpful in cases of advanced, refractory hear failure patients.

As compared to the traditional approach where an LVAD is implanted through sternotomy which requires a vertical incision down the middle of the chest, the new approach involves implantation of the HVAD system through thoracotomy. In thoracotomy, a small lateral, surgical incision is made between the patient’s ribs on the left side of the chest.

The approval has been given on the basis of results obtained from LATERAL prospective clinical trial conducted at 26 US and Canada sites. The total number of subjects were 144 having end-stage heart failure and eligible for heart transplant. The Primary endpoint was met which was non-inferiority of the HVAD implanted via thoracotomy with 88.1% of subjects experiencing survival at six months being free from disabling stroke, device explants or exchange due to malfunction. The secondary endpoint was also met which was decrease in total duration of hospital stay and in the trial hospital stay duration reduced from an average 26.1 days to 18 days. The results obtained also showed that overall survival among patients who received an HVAD through the thoracotomy approach was 88.8% at one year. According to the principal investigator Edwin McGee, “LATERAL trial demonstrated that thoracotomy is a safe and effective implant technique for the HVAD System, which gives physicians added flexibility in treating a broad range of patients.” Additionally the thoracotomy approach showed improvement in patients’ quality of life and functional capacity, supported by strong safety and effectiveness data.