The Zacks Analyst Blog Highlights: Edwards Lifesciences, Medtronic, Boston Scientific, St Jude Medical & Johnson & Johnson - ...
January 09 2012 - 3:30AM
Zacks
For Immediate Release
Chicago, IL – January 9, 2012 – Zacks.com announces the list of
stocks featured in the Analyst Blog. Every day the Zacks Equity
Research analysts discuss the latest news and events impacting
stocks and the financial markets. Stocks recently featured in the
blog include Edwards Lifesciences (EW),
Medtronic (MDT), Boston Scientific
Corporation (BSX), St Jude Medical (STJ)
and Johnson & Johnson (JNJ).
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Here are highlights from Friday’s Analyst
Blog:
Heart-to-Heart: Evolving TAVR Market
The past few years were challenging for the medical devices
companies due to widespread economic uncertainty, reimbursement
pressure and declining procedure volume. The ripple effects of
these events took a heavy toll on the industry across the board.
The companies were forced to look for other solutions to manage
their top line.
In addition to restructuring initiatives and focus on emerging
markets, the target was primarily on nascent technologies. In a
sector where innovation and state-of-the-art medical technology is
the name of the game, it becomes practically indispensable in a
weak and languishing market.
In this context, transcatheter aortic valve replacement ("TAVR") is
a much sought after technology in the medical devices space with
many players adopting the acquisition route to imbibe the know-how.
With the first human TAVR procedure performed in 2002 by Dr. Alain
Cribier, the technology has come a long way as an alternative
option for treating patients with aortic stenosis. The FDA has
hitherto approved TAVR only
for senile aortic stenosis.
What is at Stake?
Senile aortic valve stenosis is a progressive, age-related disease
caused by calcium deposits on the aortic valve that cause the valve
to narrow. As the heart works harder to pump enough blood through
the smaller valve opening, it eventually weakens, leading to
problems such as fainting, chest pain, heart failure, irregular
heart rhythms ("arrhythmias"), and even cardiac arrest.
After the onset of these symptoms, more than half of the patients
succumb within a couple of years. Open heart surgery seems to be
the standard of care to restore the normal blood flow by replacing
the diseased valve.
However, many patients with age working against them along with
myriad complications are deemed unsuitable for this surgery. As per
estimates, approximately 300,000 people worldwide have been
diagnosed with severe aortic stenosis, of which approximately
one-third are considered ineligible for open heart surgery.
The Playing Field
To meet the urgent need of patients unfit for open heart surgery,
several companies are currently working on this technology.
However, it is only Edwards Lifesciences (EW) who
holds the laurel of successfully bringing to market the Sapien
transcatheter heart valve ("THV") in the US (November 2011).
Although the Sapien was originally developed to be delivered
through two approaches – transfemoral (via the patient’s femoral
artery) or the transapical (via a small incision between the ribs)
– the FDA approval came for the former.
Edwards thus has the first mover advantage in the US market. The
largest medical devices player, Medtronic (MDT),
is however not far behind with its CoreValve. Enrollment in the US
pivotal study of CoreValve is currently on track and scheduled for
completion in mid 2012. The European market, however, is a witness
to cut throat competition with both Medtronic and Edwards in the
fray since 2007. Given the stalemate in Europe, the two players are
struggling to increase their respective market share.
Medtronic’s CoreValve portfolio in Europe includes 26mm, 29mm
and31mm valves via three access routes – transfemoral, subclavian
(through the subclavian artery located beneath the collar bone) and
direct aortic access – all based on the self-expanding platform.
Approval for the 23mm valve is expected in the second half of
fiscal 2012.
Medtronic and Edwards were the only players targeting the TAVR
market in Europe until a couple of months back. However, the
competitive landscape is likely to change with the recent launches
of two TAVR systems – JenaValve from Germany based JenaValve
Technology and Acurate TA by Switzerland based Symetis – both in
September 2011. These devices are approved for transapical
procedures only.
Pipeline Candidates
Viewing the huge potential in the TAVR market, several other
devices are under development. Candidates in queue include Engager
from Medtronic (through the acquisition of Ventor Technologies in
2009), Boston Scientific
Corporation’s (BSX) Lotus valve (with the acquisition of
Sadra Medical in January 2011), St Jude Medical’s
(STJ) Portico valve, and a valve from Direct Flow Medical.
Medtronic began a pivotal trial for the Engager system (to be
delivered through transapical approaches) in Europe in September
2011. While Boston Scientific plans to launch Lotus in EMEA in the
second half of 2013, St Jude Medical is targeting a limited launch
of the Portico valve in Europe before the end of 2012. CE Mark
trial of the next-generation (18F) valve from Direct Flow Medical
was scheduled to begin in 2011. Well
capitalized players such as Johnson & Johnson
(JNJ).
Edwards expects US approval of Sapien for high-risk ("Cohort A")
patients in mid-2012 while the FDA nod for Sapien XT ("Cohort B")
is expected in 2014. Other products under development from the
Sapien line include Sapien 3, a lower profile balloon expandable
valve and Centera valve, a low profile, repositionable
self-expanding valve, both of which will be delivered through the
14F eSheath delivery system.
Caveats for TAVR Procedures
Beyond the huge scope of TAVR, several issues are still unresolved
and need to be looked into. These issues revolve around proper
selection of patients, choosing the right delivery method, and
dealing with high risk complications including the overt risk of
stroke. To address the high risk of stroke associated with TAVR,
the FDA has asked Medtronic to include major stroke as a primary
endpoint in addition to all-cause mortality
for patients in the inoperable cohort.
On request from the Society of Thoracic Surgeons ("STS") and the
American College of Cardiology ("ACC"), the Centers for Medicare
& Medicaid Services ("CMS"), in September 2011, decided to
initiate a National Coverage Analysis for TAVR. Any unfavorable
reimbursement decision from the CMS could have an adverse impact on
this fledgling technology.
Who Will Win the Race?
Although the TAVR procedure is not without its shortcomings, as
seen above, close scrutiny of the procedures performed and proper
selection of patients are crucial for best results. The MedTech
players are all keen to have their fingers in the TAVR pie, a fact
that bespeaks of the economic potential of this specialized,
state-of-the-art procedure.
These devices are priced at a hefty premium to conventional
surgical valves. For example, Sapien has a price tag of $30,000,
way above any surgically implanted valve. However, the prevailing
economic uncertainty and the adoption of austerity measures would
force the players to increasingly compete on price.
Our Pick
Among so many players vying for a share of the TAVR market, we
believe Edwards is in an advantageous position compared to its
peers. Until recently, Edwards was the only player in the European
market with a transapical procedure (approximately half of total
volume) and was enjoying 100% of the market share. Although
competition in this space is set to intensify with new products
such as JenaValve and Acurate TA waiting in the wings, we believe
Edwards with its rich experience of more than four years is well
poised to take on the competition.
On the transfemoral side, Medtronic’s CoreValve had a larger share
before the introduction of Edwards’ Sapien XT. While the former
still has its edge, Edwards is working on closing the gap.
The current scenario in the US market is congenial for Edwards
given the head-start it enjoys compared to Medtronic. The latter is
still a couple of years away from launching its product, CoreValve,
in 2014. By that time Edwards will also be ready to compete with
its next generation Sapien XT valve and, on top of it, with more
than two years of experience.
Acknowledging the shortcomings of TAVR, we expect the technology to
nonetheless succeed in deepening its penetration level. However,
the developmental path will involve several modifications and check
points, which we believe is only the right thing to do given the
severity of the disease and human life at stake.
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BOSTON SCIENTIF (BSX): Free Stock Analysis Report
EDWARDS LIFESCI (EW): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
MEDTRONIC (MDT): Free Stock Analysis Report
ST JUDE MEDICAL (STJ): Free Stock Analysis Report
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