UPDATE 1-Redesigned Edwards heart valve shows improvement in study

Sun Mar 10, 2013 2:53pm EDT

* Sapien XT, Sapien show similar death, stroke rates at 1 yr
    * Fewer complications seen with newer XT model after 30 days


    By Bill Berkrot
    SAN FRANCISCO, March 10 (Reuters) - A smaller, redesigned
version of Edwards Lifesciences' non-invasive heart valve
replacement system called Sapien XT performed well and led to
fewer complications than the original Sapien, according to data
from a clinical trial presented on Sunday.
    Both versions, known as transcatheter aortic valve
replacements (TAVR), allow surgeons to replace diseased heart
valves by threading the new valve into place through an artery
via a catheter, sparing patients chest cracking, open heart
surgery.
    The XT has been available in Europe since 2010, while only
the more cumbersome version, which the company and physicians
consider to be obsolete, is still being used in the United
States as Edwards compiles data it will use to seek U.S.
approval for the new model.
    "With the new device, we can treat patients who have smaller
vessels with less injury and less trauma and the valve
positioning is more precise," said Dr. Martin Leon, a co-lead
researcher of the study of 560 patients deemed too frail to
endure open heart surgery.
     The study, which was presented at the American College of
Cardiology scientific meeting in San Francisco, was designed to
show that the XT is non-inferior, or at least as safe and
effective, as the older version.
    The study's primary goal looked at a combination of death,
stroke and need to be readmitted to a hospital after one year,
and the results were nearly identical for the two systems,
researchers said.
    The death rate at one year was 22.5 percent for the Sapien
XT and 23.7 percent for Sapien. After one year, 5.9 percent of
those who got the newer model had suffered a stroke compared
with 5.7 percent for the old version.
    Vascular complications were reduced by 40 percent with the
newer model, researchers found.
    Because there had been concerns about complications,
especially strokes, closer to the time of the procedure with the
original Sapien trials, researchers provided detailed 30-day
results and were encouraged by what they found.
    "All the things you expect from a smaller device were born
out here," Leon said.
    At 30 days after implantation the rate of death for any
cause was 3.5 percent for Sapien XT compared with 5.1 percent
for the original device. While the result favored the XT, the
difference was not deemed to be statistically significant.
    "It's about the lowest 30-day mortality I have ever seen in
TAVR and it happens to be in the sickest of the sick patients,
so even though it's not statistically significant, directionally
it's encouraging," Leon, director of the Center for
Interventional Vascular Therapy at Columbia University Medical
Center in New York, said in an interview.
    Patients in the study had a mean age of 84, had severe
aortic valve disease and more than 96 percent suffered from
moderate to severe heart failure.
    "I think these results are superb," said Dr. Gary Mintz,
chief medical officer of the New York-based Cardiovascular
Research Foundation, who was not involved in the study.
    "It's fundamentally a better, easier device to use," he said
of the XT.
    Strokes at 30 days was low and nearly identical at 3.2
percent for Sapien XT and 3 percent for the original Sapien,
which was also much lower than in prior Sapien trials.
    "We frankly didn't expect that there would be an important
difference in stroke. What is encouraging is when you compare it
to the Partner 1 study the stroke rates are almost half in both
arms, so stroke rates seem to be going down," Leon said,
referring to an earlier Sapien trial.
    There was a statistically significant reduction in major
valvular complications, including vessel perforations and
dissections, at 9.5 percent for XT and 15.2 percent with Sapien.
    There was also a statistically significant reduction in
anesthesia time as patients spent less time on the operating
table if they were getting the smaller device. 
    Other measures also favored the new model. With Sapien there
were 10 cases in which a second valve had to be implanted
compared with three for the XT, and there were eight aborted
procedures with Sapien versus two with XT.
    "We are very pleased to see improved outcomes in both the
Sapien and Sapien XT patients, as compared to results from
earlier trials," Larry Wood, head of transcatheter heart valves
for Edwards, said in a statement. "The Sapien XT valve was
designed to reduce complications of the TAVR procedure, and we
believe this has been demonstrated by today's results."
    The transcatheter valves are widely considered to be
Edwards' most important product line. 
    The market for transcatheter aortic valve replacements is
expected to reach $2 billion by 2016, according to BMO Capital
Markets analyst Joanne Wuensch, and that will almost surely 
grow with the aging of the enormous baby boom population.
    In the fourth quarter, Edwards reported transcatheter heart
valve sales rose 73 percent to $161 million.
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