Edwards Lifesciences Corporation
) revealed positive data from the latest post-hoc analysis of
Edwards Sapien valve from The Partner Trial at the ESC Congress
2013 in Amsterdam.
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Per the findings, high surgical risk diabetic patients who suffer
from aortic stenosis faced 35% lower relative all-cause mortality
after a year of transcatheter aortic valve replacement (TAVR)
treatment instead of surgical aortic valve replacement (AVR).
Edwards gained the regulatory approval for use of Sapien valve to
treat inoperable patients from the U.S. Food and Drug
Administration (FDA) in November 2011. The company won the
approval for high-risk surgical patients in October 2012.
The PARTNER trial, the foremost randomized, controlled clinical
trial, is evaluating Edwards' transcatheter aortic heart valve in
both operable but high-risk (Cohort A) and inoperable (Cohort B)
patients with severe aortic stenosis in the U.S. The enrolled
diabetic patients were treated as high-risk cohort of the trial.
The mortality rate for diabetics who received TAVR treatment was
18% compared with 27.5% for those who received the AVR treatment.
Moreover, diabetic patients who received TAVR treatment recorded
brisk recovery and improvement in quality of life. These patients
also witnessed lower possibility of renal failure in a year.
While clinical investigators of The Partner Trial view the
analysis as hypothesis generation as opposed to hypothesis
validation, the trial data demonstrates high probability that
TAVR will turn out to be a favored treatment for acute aortic
stenosis diabetic patients but at high surgical risk.
TAVR as the preferred treatment for high-risk diabetic patients
who suffer from aortic stenosis should expand Edwards'
addressable market. Given the exponential rise in incidence of
diabetes, the uptake of Edwards' Sapien valves in the U.S. for
diabetic patients who suffer from aortic stenosis is likely to
accelerate U.S. Sapien sales.
Notably, TAVR is one of the most promising clinical opportunities
in the cardiac device space. We also believe that Sapien valves
and its slimmer version Sapien XT (yet to be commercialized in
the U.S.) offer exciting long-term revenue opportunities.
Further, the market opportunity is likely to grow significantly
on the back of demographic trends and increasing awareness.
However, Edwards' dominance in the TAVR space is likely to face
challenges as other players in the cardiac device space are
slowly but steadily progressing well with their TAVR devices. The
company's gains from its leadership position might come to naught
in the future following approval of a competitor's product.
Currently, the stock carries a Zacks Rank #3 (Hold). Other
players who are picking up pace in the space to cater to the TAVR
market in the U.S. like
St. Jude Medical
) also carry Zacks Rank #3. On the other hand,
Boston Scientific Corporation
), which is progressing well with its TAVR trial, carries a Zacks
Rank #2 (Buy).