Medtronic has reported positive preliminary results from the HVAD LATERAL clinical trial of a full-support ventricular assist device (VAD) 'HVAD system' to treat patients with advanced heart failure.
HVAD system is a mechanical pump designed to circulate blood in the body through a less invasive procedure called thoracotomy.
The results indicated that the trial has met its primary endpoint at six months, with 87.6% of subjects being alive and free of disabling strokes, having received a heart transplant, or transferred due to recovery.
The prospective LATERAL trial evaluated the thoracotomy implant technique that is performed by making a small, lateral, surgical incision on the left side of the chest, in between the ribs.
At 30 centres in the US and Canada, the trial recruited 145 patients who have not responded to conventional medical management and are eligible for heart transplantation.
Medtronic Heart Failure business vice-president and general manager David Steinhaus said: "The LATERAL trial represents positive, contemporary results with the HVAD System, with overall survival rates of nearly 92% at six months.
"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."
It is reported that the implant of the left VAD device through the thoracotomy technique preserves the chest for a subsequent sternotomy.
The adverse events found at 30 days of the trial include cardiac arrhythmia, right heart failure, bleeding requiring reoperation and stroke.