HeartWare implants first mini heart device

By Helen Schuller
Thursday, 01 September, 2005

US artificial heart firm HeartWare (ASX:HTW) has successfully commenced its animal studies by implanting its Miniaturised Ventricular Assist Device (MVAD) in a calf.

"The commencement of animal trials is an important milestone in the early development of the MVAD device," said HeartWare's director of corporate development, Howard Leibman.

Implanted by Dr Mark Slaughter, director of mechanical support systems at Chicago's Christ Hospital, it is the first in a number of acute studies to be conducted over the next six months.

"The MVAD was left in the animal for only 24 hours -- the purpose was to test the placement and implant procedure of the device and confirm its function," said Leibman.

The MVAD is a minaturised implantable mechanical blood pump. With a volume of five cubic centimeters, the MVAD is approximately one tenth the size of HeartWare's HVAD, which the company claims is the smallest 'third generation' pump under development. Like the HVAD, the MVAD is designed to provide up to 10 litres of blood per minute. A normal adult requires approximately 7 to 10 litres to support mild to moderate exercise.

"It is 10 times smaller than the HVAD and represents a quantum leap in technological advancement in LVAD development," said Leibman. "The most exciting prospect relating to the MVAD is its potential to be implanted by minimally invasive surgical techniques. This will potentially allow the procedure to be carried out by cardiologists, while the current LVAD devices are implanted by cardiac surgeons. This will very significantly expand the clinical and commercial potential for the miniturised device."

HeartWare is planning a series of long-term animal implants of the MVAD device following the acute studies and is expected to reach the clinic approximately two years later. The company's lead device, the HeartWare HVAD, is expected to commence human clinical trials in the first quarter of 2006.

"The development of the MVAD is at an early stage -- approximately 24 months behind the HVAD -- but it represents true next generation LVAD technology," said Leibman.

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