By Dow Jones Business News, March 11, 2013, 05:54:00 PM EDT
--Edwards Lifesciences' heart-valve continues to show durability over three years
--Trial data suggest a complication of the device continues to increase mortality
--Physicians seen placing a greater premium on valves that reduce leak complication
(Updates with information about a complication related to the valve and comment from physicians in paragraphs six
By Joseph Walker
SAN FRANCISCO--The march to make open-heart surgery a thing of the past continues.
Edwards Lifesciences Inc. ( EW ) said its Sapien nonsurgical heart valve for elderly patients showed equivalent
effectiveness to surgery over three years during a clinical trial, which could provide further support for using the
medical device over surgery despite its higher cost and uncertain safety.
The updated clinical data, presented Monday at the annual scientific meeting of the American College of Cardiology,
compared Edwards's heart valve to traditional open-surgery valve replacement in patients who were eligible to undergo
The rates of all-cause mortality were roughly equivalent between the groups, with a death rate of 44.2% among the
Sapien group and 44.6% in those undergoing traditional surgery. Some physicians have worried about the device's long-
term durability, investigators in the Edwards-funded trial said, but the new data continued to show the product's
"There seems to be no structural deterioration thus far," said Vinod Thourani, co-director of the Structural Heart and
Valve Center at the Emory University School of Medicine. "It works as it's supposed to work."
Even as the new data supported continued use of the procedure, its risks came into sharper focus. Patients receiving
the device have a much higher chance of aortic regurgitation, where the heart valve doesn't close tightly and causes
blood to leak, which has been associated with increased risk of death.
The three-year data showed that patients with even mild regurgitation had a higher rate of death than patients who
experienced little to no regurgitation, a result that surprised some physicians at the meeting even though it wasn't
statistically significant. As the devices--still in their infancy--evolve and become more sophisticated, physicians
predicted that there would be a premium placed on stopping aortic regurgitation.
"Companies that have valves in their pipelines that reduce leaks should be robustly looked at," Dr. Thourani said in
Edwards shares fell 2.5% to $88.07 after the company's next-generation valve, Sapien XT, showed higher numbers of
patients with severe aortic regurgitation than the older Sapien device.
The complication "has been the Achilles heel" in gaining wider adoption for the devices in patients at a lower risk
for surgery, said Timothy Gardner, medical director at the Center for Heart & Vascular Health Christiana Care Health
System, in Newark, Del.
Edwards is currently seeking FDA permission to begin a U.S. trial for an even newer valve specifically designed to
prevent regurgitation. That trial could begin within the next year, Dr. Thourani said.
Competitors including Boston Scientific Corp. (BSX) are also considered to have promising valves for preventing
regurgitation, though Boston Scientific's is still years away from U.S. approval.
Edwards is considered a leader in minimally invasive valve replacement, a burgeoning market that is limited to a niche
population but which is expected to grow as technology improves and greater numbers of patients are approved for the
procedure by the U.S. Food and Drug Administration.
However, the market hasn't expanded as quickly as many analysts had hoped, due in part to insurer restrictions on who
can receive the device in the U.S., economic austerity measures in Europe and lingering safety concerns. Companies such
as Medtronic Inc. ( MDT ) and St. Jude Medical Inc. ( STJ ) also are attempting to enter the U.S. market, which Edwards has
Shares of Edwards Lifesciences have fallen 20% over the past five months on worries about the possibility for
disappointing sales of the company's devices in the near term.
The Edwards device is the only U.S.-approved alternative to heart surgery for patients with aortic stenosis, a fatal
heart-disease condition prevalent in people 75 years of age and older. Sapien was first approved for patients too sick
to undergo heart surgery, but its usage was extended last year to patients considered merely high risk.
Early trial data showed the device to have a greater risk of procedure-related stroke than surgery, but the three-year
data indicate the risk diminishes with time. Sapien patients had an 8.2% stroke rate compared to 9.3% in the surgical
arm over three years.
Open-heart surgery, a brutal procedure that requires sawing open the breastplate, is still considered the safest and
most-effective form of replacing calcified heart valves. However, devices such as Sapien--implanted with a transcatheter
tube through the groin or other access point--are thought by many physicians to be the future of valve replacement.
Write to Joseph Walker at email@example.com.
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