WorldHeart appoints director of clinical trials
Maria Bohuslawsky
The Ottawa Citizen
WorldHeart Corp. moved a step closer toward implanting its HeartSaver device into a human by 2000, appointing renowned surgeon Dr. Gerard M. Guiraudon as its clinical trials director.
Dr. Guiraudon, 67, who was medical director of the Open Heart Unit at Millard Fillmore Health System in Buffalo, New York, will oversee clinical trials of the left-ventricular assist device in animals this year and in the first human in December.
"He is a major name in heart disease," said Dr. Tofy Mussivand, president of WorldHeart Corp. and patent holder. "We believe patients are going to benefit not only in Canada but around the world."
The appointment was the only apparent reason for a jump in WorldHeart stock by $1, or six per cent, yesterday to reach an all-time high of $18.
The hopes for successful human tests -- the huge, final hurdle before the device can start saving lives and making a fortune for WorldHeart shareholders -- is giving investors palpitations. In only nine days of trading this year, the stock has jumped 56 per cent.
The human tests will be conducted at the University of Ottawa Heart Institute, which is in partnership with WorldHeart Corp.
Dr. Guiraudon, who started work this week, was not available for comment. The Paris-born Canadian has held academic and hospital positions in France, the United States and Canada, including University Hospital in London, Ont.
During his career, he gained fame for pioneering surgical procedures for arrhythmia, a potentially life-threatening condition of fast, irregular heart beats.
Researchers at the institute are playing a lead role in the race to market the world's first totally implantable heart pump.WorldHeart expects to sell the first units in 2001.
"We are no longer at the development stage," said Mussivand.
The HeartSaver has been tested so far on 27 male calves and the next step will be to formally document tests with eight calves that can survive a minimum of 90 days with the device. Results on the 10-year-old project will then be submitted to Health Canada for approval to begin testing humans.
The artificial heart is designed to help people suffering from degenerative heart failure. It is placed inside the chest next to the diseased heart and powered by external battery packs, without the need for any wires to pierce the body.
It can be used permanently or temporarily until a transplant organ becomes available and promises patients a nearly normal life.
"These are patients who would otherwise be dead," said Dr. Mussivand.
Heart failure is the leading cause of death in North America and Europe. With only a few thousand organs available for transplant each year, heart-assist devices are often a patient's last hope.
The institute's renowned surgeon Wilbert Keon is expected toimplant the device into the first patient in December if all goes according to schedule. "We want him to be first to have the honor," said Dr.Mussivand. "Because this is a Canadian breakthrough, wewant to use it first in Canadian patients."
At least six Heart Institute patients will participate in the trials, with possible expansion to heart centres in Canada, the United States, Belgium and Germany.
"If they're all alive in a month or two, then we won't add more trials," said Dr. Mussivand. "We'll go to the regulatory agencies and try to get it for wide use.
"If only 30 per cent are alive, then we'll add more trials." |
