N o v a c o r® L V A S-FACT SHEET

http://www.worldheart.com

The Statistics (as of May 7, 2002)

• 1,345 recipients 
• Of the 1,345 recipients, no deaths have been attributed to device failure and only 1.3 per cent of the pumps have been replaced. 
• On a cumulative basis, 287 recipients have been supported by their device for more that 6 months; 104 recipients for over one year; 22 recipients for over two years; 9 recipients for over three years; and 3 for over four years - statistics unmatched by any other implanted cardiac assist device on the market 

How it works
Novacor® Left Ventricular Assist System (LVAS) is an electronically powered pump, about the size of a human heart, which is implanted within the abdominal wall.

The LVAS provides circulatory support by taking over most or all of the workload of the left ventricle, the heart’s main pumping chamber. Blood enters the pump though an inflow conduit connected to the left ventricle and is ejected through an outflow conduit into the body's arterial system. 

The system is monitored by an electronic controller and powered by primary and reserve battery packs, worn on a belt around the waist or carried in a shoulder bag, or by a small bedside system. The controller is connected to the implanted pump by a percutaneous lead (a small tube containing control and power wires through the recipient’s skin). 

The system is completely self-regulating, responding instantaneously to the recipient’s changing heartbeat and circulatory demands. When a Novacor® LVAS recipient walks briskly, for example, the heart naturally beats faster and so does the pump, responding immediately to the change. Novacor®LVAS was designed primarily for long-term use, and was the only one of four devices to successfully complete stringent testing to standards set by the US National Institutes of Health for an implantable LVAS, exceeding their reliability criteria. 

Where it’s available: 
Novacor® LVAS is commercially available as a bridge-to-transplantation in Europe, parts of Asia, the US and Canada. In Europe, it is also available without restriction including to support patients who may have an ability to recover use of their natural heart.In Japan, the device is currently commercially approved for use in cardiac patients at risk of imminent death from non-reversible left ventricular failure for which there is no alternative except heart transplantation. 

A clinical trial is underway in the United States and in Canada to evaluate long-term use of the device as an alternative to medical therapy. The multi-center INTrEPID trial (Investigation of Non-Transplant-Eligible Patients who are Inotrope Dependent) compares survival rates and quality of life between late-stage heart failure patients who receive Novacor® LVAS and those supported by the best available pharmacological therapies. The first recipient in the INTrEPID trial surpassed one year of support in early 2001. 

Document submitted by (Michelle.Banning@worldheart.com) on Wed, 8 May 2002. 

For use on deanmoore.info to bring awareness.

Note: This is the pump Dean Moore is using to keep him alive!!

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