A Smaller, Sleeker Heart Pump

Less intrusive and better-designed devices are in the worksand

analysts predict profits for the companies that make them
Back in 1982, Barney Clark, a 61-year-old dentist, was implanted
with the world's first artificial heart, the Jarvik-7, a cumbersome
piece of equipment with complicated external mechanisms. The
device, which extended Clark's life for 112 days, required the patient
to be hooked up, via hose-like tubes emerging from his chest, to a
machine the size of a laundry dryer. The machine supplied bursts of
air that helped to pump the mechanical heart.
Today's medical-device designers foresee a more independent
existence for patients suffering from heart failure. Just as the
designers of popular consumer electronics such as Apple's (AAPL)
iPod or Motorola's (MOT) RAZR phone have been able to slim their
products to wafer-thinness, medical engineers and consultants are
employing similar strategies and innovations to create slimline
devices that are genuinely life-enhancing.
The current Holy Grail of heart-device design is an implanted, biocompatible heart pump that helps an ailing organ (versus fully
replacing an organic heart). It's so tiny, quiet, and devoid of
complicated, power-churning apparatus as to be virtually
undetectable.
A fresh vision of such a device can be found in the Levacor, under
development by Oakland, (Calif.)-based WorldHeart (WHRT),
named in June, 2006, as one of "50 Companies to Watch" by trade
publication Medical Device & Diagnostic Industry (MDDI).
WorldHeart's annual sales figures for 2005 reached $11.6 million.
Currently, the Levacor is the simplest implantable andhere's the
key to its distinctive technologymagnetically levitated rotary heart
pump now in feasibility trials (in Europe).

WorldHeart's Initial Goals

Still very much in the development stage, and yet to enter U.S.
clinical trials (meaning FDA approval is far off), Levacor was born
nearly 15 years ago. Pratap Khanwilkar, vice-president for rotary
systems and business development at WorldHeart, says that the
initial teamof which he was a memberbegan by analyzing
problems with existing heart-pump technology. (At the time,
Khanwilkar's team was working under a different company name,
Medquest. World Heart acquired Medquest in 2005.)
"Our goals were to deliver a pump in a package small enough to fit
in a range of bodiesteens as well as adults of all sizes. One that
wouldn't stop working in a year or two, and could have the potential
for long-term use," recalls Khanwilkar, who holds a PhD in
bioengineering.
In other words, they sought to create a pump that a patient could, if
very young, grow old withor, if elderly, grow older withwithout
having to replace it and undergo the stress of repeat surgery. The
idea is called "destination therapy" in the medical world.
"The pump would have to be gentle to blood cells, so as not to
rupture them, and at the same time vibrate as little as possible and
require low power consumption," Khanwilkar adds.
Gradual Improvements
Khanwilkar and his colleagues turned to a technology that no other
blood pumps or other heart devices incorporated in the early 1990s:
magnetic levitation, which is more typically used for larger
engineering projects, such as high-speed power turbines or trains.
Khanwilkar and his team reasoned that magnetic levitation "could
provide the greatest safety and had potential for high durability," he
says, because the parts didn't have to come into contact with each
other.

Instead, carefully balanced magnetic fields suspend the rotor so it

can move without coming into contact with other parts, eliminating
the need for bearings or shock absorbers. This translates into no
friction, heat, or wear-and-tear on the pump, meaning the device
could last longer.
In the ensuing years, the design team worked with LaunchPoint
Technologies, a Goleta, (Calif.) engineering firm, to create the
smallest and simplest proprietary magnetic levitation system
possible. The objective was to provide a continuous-flow pump with
a circular rotora single moving partto push blood from the ailing
heart to circulate through the body. Full magnetic levitation, which
allows the rotor to suspend fully, also allows for less obstruction for
blood flow, thus preventing dangerous clots.
The team relied on mathematical calculations, based on the physics
of both blood flow and magnetic levitation, to determine the rates by
which blood particles could be preserved as they would move
through the pump, and other technical concerns. At first they
organized their computations in an Excel spreadsheet until they
could reach dimensions that represented a small enough version of
the magnetic levitation device.
Then they created CAD models of smooth-surfaced, compact shells,
before finally building a physical prototype out of transparent
plastic. This ghostly version made it possible to observe liquid flow,
which they simulated with a blood substitute.
Smaller Designs
The current version of the Levacor, made from a titanium alloy that
is often used in implanted orthopedic devices, is smaller than a
typical adult human heart, about the size of an ice hockey puck. It's
a quarter of the size of WorldHeart's previous implantable heart
pump, and is inserted into the patient's abdomen, with blood
entering the pump via the heart's left ventricle and exiting the pump

into the circulatory system. Patients must wear a battery pack and
electric controller that is strapped close to the body.
The first human to receive a Levacor was a 67-year-old male who
took part in the feasibility trials in March, 2006, in Thessaloniki,
Greece. The patient was able to climb stairs 50 days after the
procedure and is currently living at home. WorldHeart (and
LaunchPoint) is also working with the University of Pittsburgh to
develop an even smaller version of the device for babies, only 22mm
in diameter and 43mm in length.
"[The Levacor] is an elegant and efficient-looking design, one that is
compact and bio-compatible," observes MDDI's co-editor, Erik
Swain. "It's a real contrast to the public perception of the previous
artificial hearts or heart pumps, such as the Jarvik-7."
Improvements Bring Profits
Doctors and patients aren't the only ones who are banking on
sleeker, less-obtrusive implanted heart pumps such as the Levacor.
Analysts are starting to note that demand for more comfortable,
longer-lasting heart-pump devices will start to risemeaning there
could be increased profits for the companies that make them.
In late December research notes, First Albany analyst Jason Mills
and J.P. Morgan Securities analyst Taylor Harris both stated that
the potential for an implantable device by heart-pump market
leader Thoratec (THOR) could grow dramatically, after Medicare
unveiled a proposal to expand the list of hospitals authorized to
implant the pump.
Thoratec's annual sales figures for 2005 were $201 million. The
device in question is the HeartMate XVE, currently the only longterm, implanted heart pump of its kind on the market.
As the American population ages and experiences increasing life
expectancy, the need for longer-term heart pumps will surely

increase as well. Companies such as WorldHeart could see a

booming market for their devices.
The American Heart Assn.'s 2007 heart disease and stroke statistics
state that nearly 80 million American adults have at least one type
of cardiovascular disease, ranging from high blood pressure to heart
failure. Approximately 5 million suffer from heart failure.
The "Medical Consumer"
And industrial designers believe that the look and feel of medical
devices is in need of a much-needed makeover to appeal to aging
Baby Boomers who are active and youthful. This demographic
"wants to live, and demands, a full, rich life. The Boomer market
drives research dollars among medical-device companies," observes
Allan Cameron, principal designer at Boston consultancy
Continuum.
"There's a different driver now: lifestyle. Now we have medical
consumers, a market that didn't exist 20 years ago."
The Levacor, with its tiny size and promise for durability, might
represent a future niche within the heart-pump market itself. Jeffrey
W. Nelson, president of Thoratec's cardiovascular division, says that
Thoratec is also developing its own bearingless, magnetic levitation
pump, the Heartmate III, though he adds that the company is at
least a year away from human clinical trials.
It's clearly too early to predict the widespread, long-term potential
of such next-generation, magnetic levitation heart pumps. But the
Levacor case study illustrates that medical-device designers,
engineers, and doctors are increasingly willing to take the pulse of
patients' needs and wants as consumers, taking into consideration
factors of lifestyle and longevity while developing ever safer,
stronger, and sleeker devices.
The Levacor Heart Pump

Case Study 1:
The Levacor Heart Pump
Product Management, Innovation & Commercialization
Songbo Qiao
900143
Based on the description in this case, discuss the new products process apparently
underway at World Heart, in comparison to that outlined in this chapter. How is it
similar or different? The launch phase is, of course, still well into the future at the
time the case occurs. What are the problem areas the company might face at the
time of launch? At the time of the case, what are the uncertainties that still exist?
What could the company do now to manage these uncertainties?
Based on the description of this case, the new products process of Word Heart is
similar to the outlined in this chapter. Recent 20 years, the medical consumers is
increasing; a group of people wants to live a longer, wonderful live instead of simple
one. The factor is that people who got heart disease before, after doing the
operation, do not able to live like a normal life. Therefore, those patients are eager
to live a independent and freedom life. According to this situation, World Heart
select a high potential opportunity- develop implantable heart pumps that assist the
patients own heart, rather than mechanical devices that actually replace the heart
and begin customer involvement.
World Heart evaluates new products concepts on technical, marketing, and financial
criteria. Following, one of the most promising mechanical devices is selectedLevacor. However, the trials in Europe are feasibility only a few months, in United
States Levacor is not capable obtaining approval. At that time the most exceptional
feature of Levacor is magnetic levitation. World Heart specifies the full development
process and its deliverables. Together with an engineering firm, Launch Point
Technologies, they developed a small, proprietary magnetic levitation system that
could serve to pump blood from the heart throughout the rest of the body.
Problem: When World Heart launches this...

INTEGRIS IS FIRST IN NATION TO

IMPLANT LEVACOR HEART PUMP

INTEGRIS Baptist Medical Center makes heart

technology history by implanting the nations first
WorldHeart Levacor VAD
Dr. James Long Co-invents Device
Dr. Doug Horstmanshof Launches National Clinical
Trial
OKLAHOMA CITY - Ventricular assist devices (VADs)
such as the revolutionary, next-generation Levacor
VAD, are serving up the technological breakthroughs
by which the long sought after goals of artificial heart
replacement may finally address the needs of
thousands of patients with advanced heart failure
needs that cannot be met by heart transplantation
alone.

Levacor VAD implantable blood

pump

This represents a great milestone for the field, for Oklahoma and for me personally,
says James Long, M.D., Ph.D., cardiovascular surgeon and director of the INTEGRIS
Advanced Cardiac Care program. He and a team of scientists and engineers from
around the world have been researching the device for approximately 10 years. In fact,
Long is one of the co-inventors of the technology and a leader in its early development.
When Dr. Long came to Oklahoma recently to direct the INTEGRIS Advanced Cardiac
Care program, he set a goal of bringing the most technologically advanced therapies for
heart failure to the region. INTEGRIS Baptist Medical Center in Oklahoma City, with its
worldclass team of heart failure experts, was chosen as the inaugural site for the U.S.
clinical trial of the Levacor VAD. This represents a significant step forward for
Oklahoma, says Long. To be able to offer the best medical opportunities in the world to
Oklahomans and patients in surrounding areas is one more benchmark for INTEGRIS
Health and the state as a whole.
After extensive pre-clinical testing and preliminary evaluation in Europe, the Levacor
VAD was approved by the FDA for clinical evaluation in the United States (under an
Investigational Device Exemption (IDE) for a Bridge to Transplant study). Levacor is a
next generation heart pump that is in reality a continuous flow device, meaning blood is

constantly being drawn from the heart and circulated throughout the body. There is no
pumping action required.
In actuality, the blood is propelled through the body by a rotating disc suspended in a magnetic
field. The rotor is the pumps only moving part and it floats in a magnetic field virtually
eliminating all contact and friction that can lead to wear and tear. The hope is that this design
will make Levacor a long-lasting device, with the greatest durability of any VAD currently
available. The leading first generation device lasted only a year and a half before requiring
another operation for replacement.

Patient safety was also a focus of the Levacor design. The magnetically suspended
rotor and pump configuration derived through sophisticated computer modeling is
intended to avoid trauma to delicate blood cells and minimize the potential for clots or
the need for aggressive anticoagulation with risk of bleeding.
Another potential benefit of the Levacor device is modularity with all of the
components of power delivery being individually replaceable. With the existing
technology, if there is a problem with one component many times the entire pump will
need to be replaced. As designed, this should not be the case with Levacor.
Of course improved durability, safety with blood
handling and exchangeability are only potential
advantages of the Levacor, still considered to be an
investigational device. Even though pre-clinical
testing looks promising, all of the potential benefits
have to be confirmed in clinical evaluation. That is why
INTEGRIS Baptist Medical Center is participating in the
FDA approved, national clinical trial.
Douglas Horstmanshof, M.D., cardiologist and co-director of
the INTEGRIS Advanced Cardiac Care program is the
principal investigator of the clinical trial at INTEGRIS Baptist
along with cardiothoracic surgeons Drs. Craig Elkins, John

Sketch of implanted Levacor VAD

anatomic placement showing
are blessed to have outstanding experts and patients
external wearable
launching a clinical trial of innovative heart pump
controller and rechargeable
technology, says Horstmanshof. How fitting for the modern
battery pack
Chaffin and Paul Kanaly as co-principal investigators. We

spirit of pioneering in Oklahoma!

Patients who qualify, specifically those declining while waiting on the heart transplant
list, will be given a choice. After a thorough, objective review, they can choose to be
implanted with an FDA-approved device or they can opt to participate in the clinical trial
and be implanted with the investigational Levacor device.
So far, two INTEGRIS patients have undergone Levacor VAD implantations, the first two
in the nation. Results will be analyzed at the conclusion of the study expected to enroll
160 patients nationwide.
Heart failure patients who are not Levacor candidates have a variety of other options.
The INTEGRIS Advanced Cardiac Care program offers a full array of services. Virtually
every type of modern medical therapy is now available to heart failure patients in the
state of Oklahoma.

UPDATE 1-World
Heart says will end its
Levacor heart pump
study
* To cut 42 pct of its workforce

* Says restructuring plan to result in $1.6-$2.3 mln cash

expense
* Sees $1.0 mln in severance benefits
* Sees $3-$5 mln in addl charges
* Shares at year-low

July 29 (Reuters) - Heart devices maker World Heart

Corporation said it will end its Levacor heart device
study, for a delay related to changes previously made
in the device, and said it would cut its workforce by 42
percent, sending its shares down to a year-low.
The device, Levacor Ventricular Assist Device, is a
magnetically levitated centrifugal heart pump to provide
unobstructed blood flow for adults who suffer from latestage heart failure.
However, World Heart said it will keep providing
technical support to existing Levacor VAD recipients
and clinical centers.
In February, the company had suspended patient
enrollment for its heart device study as it awaited
regulatory approval for changes made in the device.
The company said it would now focus its resources on
PediaFlow and MiFlow VADs, its minimally invasive
ventricular assist devices that are currently in
development.
In a regulatory filing, World Heart -- which had 65 fulltime employees, as of March 15, -- said severance and
benefit payments are expected to total about $1 million.
It also expects $3-$5 million in additional restructuring
charges related to inventory and equipment writedowns.

The company expects about $1.6-$2.3 million of

aggregate cash expenditures because of the
restructuring plan. About $1.5-$2.0 million of this may
be in the third and fourth quarters of 2011 and the
remainder in 2012.
World Heart shares fell 39 percent to a year-low of 52
cents on Friday on Nasdaq. (Reporting by Shailesh
Kuber in Bangalore; Editing by Joyjeet Das)

WorldHeart shutters Levacor VAD program, ends

trial enrollment
Justine Varieur Cadet
Aug 01, 2011

WorldHeart has ended efforts to commercialize its Levacor ventricular assist device (VAD)
and will cut its workforce by 42 percent. The company said it will no longer enroll
participants in the Levacor bridge-to-transplant (BTT) clinical study but will continue to
provide technical support to recipients of the devices and their clinical centers.
Salt Lake City-based WorldHeart, which manufactures VADs for adults, children and infants
with heart failure, cited a delay linked to modifications in the Levacor device for its
regulatory decision. In February, WorldHeart announced that it had suspended enrollment in
the BTT study while it awaited notification from the FDA. It had made changes to the Levacor
VAD, which uses a bearingless, fully magnetically levitated implantable centrifugal pump, to
address design issues.
At the time, it characterized the FDAs review and approval as uncertain."
With the lengthening BTT clinical study delay associated with the previously announced
device refinements, the company does not believe the Levacor VAD can be competitively
commercialized, according to a July 29 statement.
According to filings with the National Institutes of Health, the company planned to enroll
approximately 160 patients to study the safety and efficacy of the device in candidates
needing a cardiac transplant with presumed non-reversible left ventricular failure. The BTT

study was launched in August 2009 and was scheduled to be completed by October 2012.
Six hospitals participated in the study.
WorldHeart said that it will focus its resources on smaller, next-generation PediaFlow and
MiFlow technologies. The company suggested that the small size of these devices will lead
to less invasive VAD surgeries with faster patient recovery times while retaining the blood
handling characteristics of the Levacor VAD.
Both PediaFlow and MiFlow technologies are under development. Alex Martin, president and
CEO of WorldHeart, said that the company expected to begin animal studies on the MiFlow
VAD in 2012 and clinical trials in Europe in 2013. The PediaFlow VAD has been in
development since 2005.