UPDATE 2-Abbott heart clip durable, safe at 2 years -study

* 78 pct of MitraClip patients needed no surgery at 2 yrs

* MitraClip and surgery death rate statistically similar

* Device could be available in United States by end of 2011

* Abbott shares up 1.9 percent
(Adds data, researcher comments, background, updates shares)

By Bill Berkrot and Debra Sherman

NEW ORLEANS, April 4 (Reuters) – A minimally invasive
technique from Abbott Laboratories Inc (ABT.N: Quote, Profile, Research) to repair the
most common type of heart valve problem demonstrated durability
after two years with similar long-term safety to surgery,
according to data from a study presented on Monday.

Abbott’s MitraClip to repair a leaky heart valve condition
called mitral regurgitation (MR) had previously demonstrated
far greater safety than open heart surgical repair at 30 days
and promising effectiveness after one year in the 279-patient

The new data presented at the American College of
Cardiology scientific meeting looked at those patients two
years after MitraClip repair.

“The key findings between one and two years is that very
little has changed,” said Dr. Ted Feldman, one of the study’s
lead investigators, who presented the data. “We see durability
with the results of all of our measures.

“Two-year durability is reassuring to us all. It gives us a
lot of optimism,” said Feldman, the director of the cardiac
catheterization laboratory at Northshore University
HealthSystem in suburban Chicago.

Patients who had no complications within the first six
months are likely to remain stable for years, said researchers
who have followed many MitraClip patients well beyond two

Of those who received the clip device, 78 percent did not
require additional surgery at two years.

Abbott is hoping the U.S. Food and Drug Administration will
find the data equally reassuring. The device, which has been
available in Europe since 2008 and recently won Australian
approval, could gain U.S. approval by the end of this year.

With FDA approval, Abbott has an “overall revenue
expectation of several hundred million (dollars) per year
worldwide over the next few years” from the clip, said John
Capek, executive vice president for medical devices.

Abbott shares were up 92 cents or 1.9 percent at $50.29 in
late morning trading on the New York Stock Exchange.

The death rate after two years was 11.8 percent for clip
patients and 9.6 percent for surgery. Those results were
considered to be virtually identical from a statistical

Surgery proved more effective at repairing the condition,
with a clinical success rate after two years of 66.3 percent
versus 51.7 percent for patients treated with the MitraClip.

Researchers stressed that surgery remained an option for
patients for whom the MitraClip did not work early on or who
later needed surgical repair.

“It is an important consideration that surgery is sometimes
necessary after clip, but it’s also important that it can be
done successfully after clip,” Feldman said.

Both groups had improvement in left ventricular function at
one and two years, however the clip patients reported superior
symptom relief.

“After getting a MitraClip, patients spend one or two
nights in the hospital versus five to seven days after
open-heart surgery, and they’re back to full activity
immediately,” Feldman said, adding that traditional open-heart
surgery has a recovery time of one to three months.

“The contrast is pretty striking,” he said.

MR, which affects more than 8 million people in the United
States and Europe, is marked by a faulty mitral valve that does
not close tightly enough, allowing blood to flow backward in
the heart. It is a debilitating condition in which the heart’s
ability to function deteriorates over time, and can lead to
irregular heartbeat, heart failure, stroke, heart attack or

The repair device, which Abbott added to its portfolio with
the acquisition of Evalve Inc, works by clipping together the
leaflets of the mitral valve, one of four valves in the heart.
It is delivered to the heart via a catheter inserted through a
blood vessel in the leg.

“From a clinician’s perspective it’s clear to me that the
therapy is highly effective,” Feldman said.

“It’s tremendously attractive for patients who are not
candidates for surgery or patients who are at higher risk for
surgery,” he added.

For that patient population, Feldman said, “this is really
a transformational and life-changing option.”
(Reporting by Bill Berkrot and Debra Sherman; Editing by Lisa
Von Ahn and Matthew Lewis)

UPDATE 2-Abbott heart clip durable, safe at 2 years -study