February 11, 2002 08:01
FDA Approves 15 Additional Subjects for WorldHeart's Novacor LVAS Long-Term Use TriaL
Jump to first matched term
OAKLAND, CA, Feb. 11 /PRNewswire-FirstCall/ - (NASDAQ: WHRT, TSE: WHT) - The US Food and Drug Administration (FDA) has approved an additional 15 subjects for World Heart Corporation's (WorldHeart) INTrEPID destination- therapy trial.
The multi-center INTrEPID trial (Investigation of Non-Transplant Eligible Patients who are Inotrope Dependent) began enrollment in March 2000. It compares survival rates and quality of life between non-transplant eligible end-stage heart failure patients who receive WorldHeart's Novacor(R) LVAS (left ventricular assist system) and those supported by the best available pharmacological therapies.
This is the second enrollment extension approved by the FDA within the last five months. The first occurred in October 2001, when the FDA approved an addition of 15 subjects.
The recent FDA approval brings the total approved enrollment in the trial to 55 subjects. Thirty-seven subjects have been enrolled to date.
WorldHeart's Novacor(R) LVAS is an electromechanically driven pump that provides circulatory support by taking over part or all of the workload of the left ventricle. Novacor(R) LVAS is commercially available as a bridge-to- transplantation in Europe, parts of Japan and China, the US and Canada. In Europe, it has unrestricted approval for use as an alternative to transplantation and is also available to support patients who may have an ability to recover the use of their natural heart.
There have been more than 1300 Novacor(R) LVAS recipients worldwide. A total of 277 recipients were supported on their device for more than 6 months, 98 recipients for over one year; 22 recipients for over two years; 7 recipients for over three years; and 2 for more than 4 years, a record unmatched by any other assist device.
World Heart Corporation, a global medical device company based in Ottawa, Ontario and Oakland, California, is currently focused on the development and commercialization of pulsatile ventricular assist devices. Its Novacor(R) Left Ventricular Assist System (LVAS) is already well established in the marketplace and its next generation technology, HeartSaverVAD(TM), is a fully implantable assist device intended for long-term support of patients with heart failure.
SOURCE World Heart Corporation
/CONTACT: Michelle Banning, Manager, Corporate
Communications, (613) 226-4278, ext: 2995, michelle.banning@worldheart.com;
Corinna de Beer, Manager, Investor Relations, (613) 226-4278, ext: 2010,
corinna.debeer@worldheart.com/
(WHRT WHT.)
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