According to Ventracor Ltd. of Australia, the company has received a conditional approval from the FDA for a feasibility study of its cardiac assist device in the USA.
From the company’s website:
VentrAssist™ is a new third generation cardiac assist system primarily designed as a permanent alternative to heart transplants for patients suffering heart failure.
It is a blood pump that connects to the left ventricle of the diseased heart to help the ailing heart’s pumping function and assist in restoring a better quality of life.
It can also be used as a bridge to heart transplant and possibly as a bridge to recovery, where it may allow a deteriorating heart an opportunity to recuperate.
VentrAssist™ has only one moving part – a hydrodynamically suspended impeller. It has been designed to have no wearing parts or cause blood damage.
It weighs just 298 grams (10oz) and measures 60mm (2.5 inches) in diameter, making it suitable for both children and adults.
The implanted parts of the VentrAssist™ system use materials which are fully biocompatible including titanium alloys. Its components are light, strong, non-toxic and highly resistant to degradation within the body.
More at Ventracor…