CARDIONEXUS GETS A
PUSH FROM PANASONIC, FDA NOD FOR DEVICE
By JIM STOMMEN
Medical Device Daily Contributing Writer
A young Texas company that is the result of
a unique partnership involving a gigantic
global maker of consumer electronics has
received FDA approval to sell its
ultrasound-based system for the early
detection of heart disease, with sales
having begun immediately upon receipt of the
agency's go-ahead last week.
The CardioHealth Station from CardioNexus
(Houston) uses a portable ultrasound system
to perform non-invasive heart examinations
in the field. The system can detect arterial
plaque and measure the thickness of arterial
CardioNexus is a joint venture between
Panasonic Corp. of North America (Secaucus,
New Jersey) and Fairway Medical Technologies
(also Houston), whose focus is
commercialization of early-stage medical
devices and technologies. CardioNexus was
founded in January 2009 to focus on early
detection of cardiovascular disease.
Morteza Naghavi, MD, president/CEO of both
Fairway and CardioNexus, told Medical Device
Daily on Monday that use of the device has
been a "jaw-dropping" experience for
physicians who have used the CardioHealth
Station during clinical trials. "Opinion
leaders in the field have been outspoken in
their positive responses to the device," he
Naghavi said the CardioHealth Station "looks
like a big iPod," and cited its ease of use:
"You just put the device on a patient's neck
and the machine guides you; you don't even
need to push a button to proceed with the
He said the device is intended for
diagnostic use in physicians' office
settings – particularly those of primary
care physicians, internists and family
physicians, whom Naghavi said are
"absolutely our main target. They're the
ones who are underserved – they simply don't
have these kinds of devices in their
Naghavi, who is internationally recognized
as a leader in heart attack prevention
initiatives, is a serial entrepreneur who
has founded four medical companies,
including Volcano (San Diego, California), a
firm focused on detection of vulnerable
plaque, which went public in 2006. Volcano
was based on work done by Naghavi and
colleagues at the Texas Heart Institute
CardioNexus says that traditional risk
factors such as cholesterol, blood pressure,
etc., are not enough and often misclassify
patients. And traditional ultrasound
measurement of carotid wall thickness (CIMT)
is dependent on having a skilled operator to
perform the studies and "is a multi-step
process that is time-consuming to perform,"
says the company.
Naghavi said that about two years ago,
Panasonic decided to enter the healthcare
arena full speed. "They're the world's
largest electronics manufacturer, with some
380,000 employees worldwide," he said,
adding that the company "has a ton of
technology" and is listed as holding the
largest number of patents of any company
"But their decision to get into healthcare
came kind of late in the game, so they
elected to focus on 'early healthcare,' or
preventive types of medicine, as well as
home health," he said, segments where there
isn't as much competition as more
traditional market sectors.
"They're really aiming at the personalized
medicine space," Naghavi added.
The electronics giant "needed partners, so
they came to us at Fairway because they saw
my background as a preventive cardiologist
to be a good fit and we started a
relationship," he said. With Fairway and
Naghavi's track record in early detection
and treatment for cardiovascular disease,
that relationship soon blossomed into the
entity known as CardioNexus.
Simply put, the relationship is broken down
into Panasonic doing all the manufacturing
while CardioNexus does all the clinical
development and product positioning. The
initial U.S. marketing efforts will be
directed by CardioNexus, "but we'll look to
Panasonic when we're ready to move
globally," he said.
As for the science behind the CardioHealth
Station, Naghavi noted that the early
detection of cardiovascular disease "has
been an interest of cardiologists for years,
but until recently the main focus has been
on CV risk factors such as family history,
cholesterol, blood pressure and the like.
"But risk assessment has many limitations,"
he said, "and the fact is that the majority
of people who come in with heart attack
symptoms don't fit the traditional risk
profile." So organizations such as the
American College of Cardiology (ACC;
Washington) and American Heart Association
(Dallas) have recommended direct assessment
of risk via methods such as measuring
coronary calcium and the thickness of vessel
walls, "but those assessments typically
aren't available in many physicians'
offices," Naghavi said.
"The obvious solution," he said, "is
ultrasound, but the problem with traditional
ultrasound is that you need a savvy
operator, more costly high-resolution
machines, and more of a patient's time."
Enter CardioHealth Station, a device that
Naghavi said had its genesis in work begun
5-1/2 years ago. He said the device is
"newly designed, built from the ground up.
"It's a huge advantage for doctors such as
primary care physicians, internists and
family physicians – it's a very
revolutionary piece of equipment noteworthy
for its ease of use. You don't even need to
hit buttons; just place the equipment at the
patient's neck and the machine guides you."
And it only takes about five minutes to
carry out the test.
The physicians who have seen the equipment
to date say "this is mind-blowing, it's
exactly what we have needed," Naghavi said.
"It's very revolutionary."
He said he expects the CardioNexus/Panasonic
booth at the upcoming ACC meeting in New
Orleans next week to pretty much be swarmed
with physicians drawn to the new technology.
Naghavi said the companies will be
exhibiting at 20-some medical meetings over
the next several months as they roll out the
And more indications are in the pipeline
beyond risk factor profiles and IMT/plaque.
Some of the others that CardioNexus
indicates as areas of interest include
point-of-care blood testing, blood pressure
and ankle brachial index checks, and body
measurements such as height, weight and body
CardioNexus Corporation is an affiliated
company of Panasonic Healthcare dedicated to
reducing cardiovascular disease through
early detection and prevention. CardioNexus’
flagship product, the CardioHealth® Station,
is a new multi-modality initiative to
advance cardiovascular health assessment for
the prevention of heart attack and stroke.
The advanced, automated features of the
CardioHealth® Station enable
physicians, especially primary care
physicians and internists, to perform
atherosclerosis imaging and cardiovascular
risk assessment in their offices, without
need for outside referral.
Based in Secaucus, NJ, Panasonic Corporation
of North America provides a broad line of
digital and other electronics products for
consumer, business and industrial use. The
company is the principal North American
subsidiary of Panasonic Corporation (NYSE:
PC), and the hub of Panasonic’s U.S.
branding, marketing, sales, service and R&D
operations. Panasonic Corporation of North
America’s newly formed Healthcare Group
brings together Panasonic’s expertise in a
wide range of health and medical device
technologies, including hearing care. For
more information visit
Additional Panasonic information for
journalists is available at
About Panasonic Healthcare Co., Ltd.
Panasonic Healthcare Co., Ltd.,
headquartered in Matsuyama, Japan, is an
internal division company of Panasonic
Corporation (NYSE: PC) that specializes in
the development and manufacture of
healthcare products, including blood glucose
monitoring systems, ultrasound diagnostic
systems and hearing instruments. Founded in
1948, the company has been developing
cutting-edge technologies in in-vitro
diagnostic systems, medical imaging, hearing
solutions, medical instruments and hospital
systems to provide value-added solutions to
healthcare professionals and patients. The
previous corporate name was Panasonic
Shikoku Electronics Co., Ltd., which was
changed to the current Panasonic Healthcare
Co., Ltd. on October 1, 2010.