A small study showed that
Edwards Lifesciences Corp.'s
) next-generation Sapien XT replacement heart valve is superior
to the CoreValve device developed by
), in terms of overall device success. Edwards recently presented
a head-to-head comparison of Sapien XT with CoreValve at the
American College of Cardiology's annual conference in Washington.
Edwards' shares gained 6.3% in the trading session following this
impressive news release. The stock is up around 14% year-to-date.
The Choice Trial - in which Sapien XT outperformed CoreValve -
was an investigation-initiated trial involving CoreValve and
Sapien XT and was conducted on 241 patients with severe aortic
stenosis in 5 medical centers in Germany. Each of these patients
was randomly administered one of the 2 transcatheter aortic valve
The study revealed that 95.9% of the patients implanted
with the balloon-expandable Sapien XT device achieved device
success compared to 77.5% of patients confirming the same for the
self-expandable CoreValve arm.
The primary endpoint of the trial was device success, which was
defined as "successful vascular access and deployment of the
device and retrieval of the delivery system, correct position of
the device, intended performance of the heart valve without
moderate or severe regurgitation, and only 1 valve implanted in
the proper anatomical location".
Among the secondary endpoints, no significant difference was
found between the two valves with respect to cardiovascular
mortality, bleeding and vascular complications, post-procedural
pacemaker placement, and a combined safety endpoint at 30 days
including all-cause mortality, major stroke or other serious
Sapien XT's significantly lower frequency of residual
more-than-mild aortic regurgitation has enabled its success over
CoreValve. Moreover, the study validated that a heart patient
with a valve from Edward's Sapien group needs replacement at
lesser frequent intervals vis-à-vis CoreValve.
At the conference, the authors declared that the study was
limited by the use of angiography, instead of echocardiography,
during the valve implantation. Since the CoreValve device expands
even after implantation, it might have skewed the regurgitation
results against it. For obtaining elaborate differences between
the two devices, a more detailed study is necessary, as per the
In the short term, it is true that improvement of heart failure
symptoms is more frequent in patients with a Sapien XT valve.
However, in the long run, whether Sapien XT will be able to
translate its device success into clinically relevant overall
benefits, is subject to the long-term follow up of the Choice
CA-based Edwards, which globally offers surgical heart valve
therapy products, currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth considering in the medical
products industry include
). While Enzymotec carries a Zacks Rank #1 (Strong Buy),
SurModics carries a Zacks Rank #2 (Buy).
ENZYMOTEC LTD (ENZY): Free Stock Analysis
EDWARDS LIFESCI (EW): Free Stock Analysis
MEDTRONIC (MDT): Free Stock Analysis Report
SURMODICS (SRDX): Free Stock Analysis Report
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