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CMAJ Today!

WorldHeart ride not for the faint of heart

Date: July 26, 1999
Time: 10:43 am

WorldHeart Corporation, the Ottawa-based medical-devices business that hopes to corner a large chunk of the artificial-heart market, went for another loop on its roller-coaster ride last week when the company announced that a battery module powering its ventricular assist device (VAD) failed and will push back the first human trials of the device to next year at the earliest.

That a part could fail in a medical device still in the preclinical trial phase is not necessarily big news. However, when a device has the potential to change the treatment of heart failure and when the company making the device has literally millions of shares trading on North American stock exchanges, everybody listens.

"If we hadn't had the cell failure last week (July 16) our progress to date would be an unqualified success," Rod Bryden, World Heart chairman and chief executive officers told eCMAJ Today. "As it stands now, it will be up to the markets to understand the issue."

The issue is that the HeartSaver VAD's power source, a 400-g lithium battery implanted in the patient's abdomen and designed to power the device for 90 minutes, overheated and failed during testing. The internal battery acts as a backup to an external battery pack the patient wears on a belt, which can be removed during physical activities like swimming. WorldHeart expects it will take about a month to find out why the battery overheated, a delay that will make starting the first human trials in December -- the original target date -- too tight.

"I think sophisticated investors will be relieved to know we are focused on quality and are not simply pressing ahead to try and meet some self-imposed deadline," said Bryden.

Sophisticated or not, investors scrambled after the announcement of the battery's failure and share prices dropped a dollar on both the Toronto and NASDAQ stock exchanges almost immediately.

"To enable scientists such as myself to utilize the results of their work in actual human trials we need funding from outside investors because governments simply can't afford to pay for it all," said Dr. Tofy Mussivand, WorldHeart's president and chief operating officer. "While delays of 2 weeks, or even months [for clinical trials] might seem important to investors, this technology is several years ahead of its time and the most important thing is to make sure it works properly in patients."

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