Here's the article. No mention of MicroMed or others as competition. I found the $20 billion market figure for North America interesting. That must be cumulative, versus annual.
World Heart answers back against rival
ThermoCardio Systems says concept was
abandoned
Karyn Standen
The Ottawa Citizen
World Heart Corp.'s claim
that its artificial heart assist
device is at the cutting edge of
cardiac technology is being
challenged by one of the
world's top medical devices
companies, which is also one
of WorldHeart's closest
rivals.
ThermoCardio Systems Inc.
says WorldHeart is basing the
success of its HeartSaver on
a concept that past
researchers have tried and
abandoned.
"I've been there, done it," said
Victor Poirier, president and
founder of the medical
devices company based in
Woburn, Massachusetts.
"WorldHeart is putting in a
major effort to try to make
their system work, and I wish
them luck. But in my opinion,
we (ThermoCardio) didn't go
that route because we didn't
think it was the right way to
go."
WorldHeart's
HeartSaverVAD is designed
to be completely implanted in
the chest, next to the lungs,
primarily for two reasons:
One, to use the atmospheric
pressure created by the lungs
to vent any air; and two, to
use that same pressure to
move blood between the
natural heart and the device,
and to move lubricating fluid
between the device and a storage sac.
But Mr. Poirier says putting the device in the chest is a "mistake."
"There's not enough room, and there's too much lung compromise."
A diseased heart, he says, is swollen because it is struggling to pump out
blood.
Furthermore, the lungs of patients suffering from heart failure are congested,
backed up with blood because the heart has been weakened.
"To go in there (in the chest cavity) and add more hardware, thus
compressing the lung, you're essentially going to eliminate the ability of that
lung to function. I can tell you nobody else puts their equipment in the chest.
There's just not enough room."
Not so, argues Dr. Tofy Mussivand, president of WorldHeart and
HeartSaver's lead designer.
"We have scientifically proven ... that it fits in the chest. The problem is that
nobody believes it could be in the chest."
In fact, says Dr. Mussivand, WorldHeart has implanted the device, which
weighs about 500 grams, in "30-some" cadavers and found that it fits.
The device has also been placed, briefly, in the chests of eight living humans
during heart surgery, with their approval, again to see if it fits.
The enlarged heart, he says, shrinks like a burst balloon and the congested
lungs clear up once the device is implanted. "As soon as you put the device
in, it sucks the blood out, so the natural heart, which is big, shrinks in front of
your eyes. And immediately after putting the device in, the lungs become
uncongested, because congestion is the backing up of blood in the lung."
Dr. Kenneth Franco, a member of WorldHeart's clinical advisory board and
associate professor of cardiothoracic surgery at Yale University, says it is
too soon to tell what is better: putting the device in the abdomen or in the
chest.
That determination will have to wait until data from HeartSaver's human
trials, expected to begin next year, become available.
But he, too, disputes ThermoCardio's contention that WorldHeart's device is
too big to fit in a human chest, saying, "I don't think it's appropriate for me or
a competitor to say that it can or cannot work (in the chest). WorldHeart has
the (research) experience."
HeartSaver's other main rival, Novocor, a division of Baxter International
Inc. of Deerfield, Illinois, also briefly experimented with technology similar to
HeartSaver.
In the late 1980s and early 1990s, Novocor had "fully implantable systems"
that were subjected along with products from competitors to stringent U.S.
health tests, says Linda Reed Strauss, Baxter's vice-president of
communications.
Novocor passed the tests, but did not at that time continue with the
technology because "we believed that for long-term clinical use, that wasn't
the device that everyone would like to have," she said.
"There are a number of technical approaches that all hold some degree of
promise. The evolution of this field will show through clinical studies which
technologies are optimum for what groups of patients for long-term reliable
support."
As with ThermoCardio's device, Novocor's current model is placed in the
abdomen, with tubes protruding through the skin to connect the device to an
external power source and controller. Ms. Strauss adds she is not sure when
Novocor may have a fully implantable device with no skin perforations.
ThermoCardio's and Novocor's comments come at a time when analysts
and investors are clearly impressed with WorldHeart.
WorldHeart's year-over-year share value has climbed 63 per-cent, with its
stock now trading around $15.50 on the Toronto Stock Exchange. In the
same period, ThermoCardio, which trades on the American Stock
Exchange, has seen its stock drop in value by more than 54 per-cent, and
now trades around $6.75.
In July, Baxter said its cardiovascular unit, made up of five divisions,
including Novocor, will be spun off next spring so Baxter can concentrate on
"higher-profit" products used in renal therapy and blood clotting.
And Jean-Luc Berger, an analyst with Credifinance Securities Ltd., writes in
a report released last year that HeartSaver "is a ventricular assist device
believed to be superior and in more advanced stage of development than the
competition."
With five million people worldwide -- 25,000 in Canada -- dying each year
from congestive heart failure, but only 2,500 donor hearts available annually,
the race to build life-saving artificial heart assist devices has become big
business.
Roughly one dozen medical devices companies and a host of hospital
research centres have devoted millions of dollars and years of research to
developing artificial heart assist technology.
So great is the demand for these devices, say analysts, that the market in
North America and Europe is expected to reach $20 billion.
Analysts most frequently point to four medical devices manufacturers as
serious WorldHeart competitors: Thoratec Laboratories Corp. of
Pleasanton, California, Abiomed Inc. of Danvers, Massachusetts, Novocor
and ThermoCardio Systems. Unlike WorldHeart, all four have implanted
devices into humans. Novocor and ThermoCardio are currently considered
WorldHeart's closest rivals because their pumps are placed inside the body,
although Abiomed and Thoratec are in the process of developing implantable
devices. Abiomed's new product is intended to be a total heart replacement
device.
ThermoCardio recorded sales of nearly $67 million U.S. last year. It is a
subsidiary of the multi-billion dollar U.S. medical products manufacturer,
Thermo Electron Corp.
ThermoCardio president Victor Poirier says more than 2,000 people in the
U.S. have received a HeartMate while waiting for a donor organ. One
patient lived on the device for 835 days.
The company is now testing the device as a permanent implant, instead of
using it as a "bridge to transplant" that keeps a patient alive until a donor
heart becomes available. The study, approved by the U.S. Food and Drug
Administration and begun in April 1998, will follow 140 patients for two
years at up to 20 U.S. hospitals.
In addition, ThermoCardio's president says, the company is working on a
next-generation HeartMate that will be totally implantable in the abdomen
with an energy transfer system that sends power through the skin. Human
implants are expected by the "end of this year," with commercial sales in the
U.S. in three to four years, Mr. Poirier said.
The Novocor product is an electromechanical device also used to keep
patients alive until a donor heart becomes available. It has been implanted in
1067 patients in the U.S., 55 of whom have lived on the device for more
than one year and one who has lived for as many as four years, Ms. Strauss
said.
Some patients have died due to heart disease complications, but there has
not been "any patient injury or death associated with the pump stopping," she
added.
The cardiovascular division that Novocor is part of has about $1 billion U.S.
in sales.
In comparison, WorldHeart expects to begin human trials next year
(originally slated for the end of this year but postponed because of a battery
failure, which has since been corrected). An early test version of HeartSaver
has been beating non-stop for seven years, and the company has
successfully completed a number of animal trials and tests of its remote
monitoring system. It forecasts net income of about $20 million Cdn. in 2001
when HeartSaver is expected to begin full production.
Even so, WorldHeart is so confident in HeartSaver's superiority that Mr.
Bryden contends its real competition is itself.
"We don't see this as a race against the other guy. We see this as a race
against our own performance standards."
Unlike its rivals, HeartSaver is a totally implantable, permanent device that its
developers say will return patients to a near-normal lifestyle. Its
specially-designed energy transfer system, which conducts power through
the skin, and remote monitoring capability means it does not require holes in
the body. Competing products currently require people to carry battery and
control packs in external shoulder bags or belts, and put patients at risk of
infection from their open wounds. An internal back-up battery in HeartSaver
also means patients will be able to remove the external battery for up to one
hour to swim or bathe.
Another key competitive advantage for HeartSaver is the pulse it creates,
says Dr. Mussivand. It pumps blood with the rhythmic beat similar to the
natural heart's. So-called non-pulsatile devices pump blood in a steady flow,
which over a long period of time could damage internal organs, says Yale
University's Dr. Franco.
ThermoCardio's current HeartMate device is pulsatile. But in order to
eliminate the need for venting gas (and thus protruding tubes), its
next-generation device will, on its own, be non-pulsatile. So ThermoCardio
will "induce a pulse electronically be speeding up and reducing the speed of
the motor" in the pump, says Mr. Poirier.
Such a pulse, says Dr. Franco, "is not as physiologic a pulse as your
circulation or my circulation has at the present time."
As for what kind of impact that can have on the body, "Nobody really
knows the answer to that question," he said, because there is not yet enough
long-term human data.
Dr. Mussivand says a pulse that depends on electrical power could put the
patient at risk if there is a power failure, and means a patient must carry
more equipment either inside or outside his body.
In comparison, HeartSaver creates a pulse by using a valve that responds to
pressure changes between the natural heart and the artificial device. The
valve opens and closes, sending blood in a pulsing flow, when the pressure
reaches a certain point.
(Dr. Mussivand adds that the close cooperation between heart and device
means normal heart functions, such as reacting to adrenaline, can be
maintained. The natural heart can still "understand" hormonal signals that tell
it to adjust blood flow. As it pumps faster or slower based on these signals,
the device helps it by either speeding up or slowing down. The Novocor and
ThermoCardio devices provide similar responses).
WorldHeart has devoted a lot of money and talent to developing
HeartSaver. The company has raised $72 million Cdn. in three issues, with
much of the financing going toward R&D, says Mr. Bryden.
The scientific team leading and advising HeartSaver's development is a who's
who of international cardiovascular medicine. Dr. Mussivand is director of
the cardiovascular devices division at the University of Ottawa Heart
Institute and a past director of technical services at the prestigious Cleveland
Clinic Foundation, where he was involved in several artificial heart programs.
HeartSaver's clinical advisory board is led by Dr. Wilbert Keon, chief of
cardiac surgery, founder and director general of the Ottawa Heart Institute.
In short, writes analyst Jean-Luc Berger, the HeartSaver development team
has "an impressive track record."
But as both ThermoCardio and Novocor point out, it is a long road between
a concept, even one like HeartSaver that has been successfully tested on
calves, and a device that saves human lives.
"Novocor and ThermoCardio have taken products all the way through the
development cycle and through very extensive clinical trials. One thing we've
all learned is that from concept to commercialization is a very significant
effort technically, clinically, and from a regulatory standpoint," says
Novocor's Linda Reed Strauss. "What technologies prove to be the most
popular are those that take us to the ultimate objective, which is reliable,
durable, long-term support with an extremely good quality of life."
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