Last Updated on Wednesday, 23 September 2009 14:13 Written by Josh White Thursday, 24 September 2009 00:00
Heartware is an Australian company that manufactures a Ventricular Assist System. It's designed to help patient's with weakened hearts by removing blood from the left side of the heart and pumping the blood into the aorta.
A miniaturized centrifugal pump called the HVADTM is designed to rest inside the chest and can generate up to 10 liters per minute of blood flow. Two small motor stators inside the pump housing cause an impeller within the device to rotate, pumping blood through the system.
The HVAD Pump has only one moving part, the impeller, which spins at rates between 2,000 and 3,000 revolutions per minute. The impeller is suspended within the pump housing through a combination of passive magnets and a hydrodynamic thrust bearing. When the impeller spins, blood flows across inclined surfaces, creating a "cushion" between the impeller and the pump housing. There are no mechanical bearings or any points of contact between the impeller and the pump housing.
Device reliability is enhanced through the use of dual motor stators with independent drive circuitry, allowing a seamless transition between dual and single stator mode if required. The pump's inflow cannula is integrated with the device itself, ensuring proximity between the heart and the pumping mechanism. This assists with ease of implant and helps ensure optimal blood flow. The use of a wide-bladed impeller and clear flow paths through the system are expected to help minimize risk of the pump damaging blood cells or causing blood clots.
To control the pump, a cable exits the patient's skin and connects to an externally worn controller. The controller is powered by a battery pack, which incorporates two batteries or one battery plus an adaptor connecting to a wall or vehicle electricity outlet. The controller operates the pump and is designed to provide the patient with signals and alarms concerning the operation of the system. The controller and batteries are contained in a carrying case that is designed to be worn either on the patient's belt or over the shoulder.

The HeartWare System is already commercially available in the European Union after receiving CE Mark approval in January 2009.
HeartWare is currently conducting a clinical trial in the United States for a Bridge-to-Transplant indication. The first US patient was enrolled in August 2008 at the Washington Hospital Centre. The US clinical trial will enroll up to 150 patients at a maximum of 28 centers. There were 46 implants so far as of July this year. Clinical results to date have been encouraging, with a 90% survival rate at 6 months and an 86% survival rate at 12 months.
There is also a next generation platform making progress in pre-clinical studies.
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