PREVIEW-All eyes on Edwards heart valve at medical meeting

* What: American College of Cardiology annual meeting

* When: April 2-5

* New valve system to be compared with open heart surgery

* New stents, blood thinner also to get attention

By Debra Sherman and Bill Berkrot

CHICAGO/NEW YORK, March 31 (Reuters) – A potential
breakthrough heart valve from Edwards Lifesciences Corp (EW.N: Quote, Profile, Research)
that can spare patients from chest-cracking, open heart surgery
will take center stage at one of the year’s most important
heart meetings next week.

Tens of thousands of cardiologists and researchers will
gather for the American College of Cardiology Scientific
Sessions in New Orleans, a town famous for its artery-clogging
cuisine, to discuss the latest advances in heart devices, drugs
and procedures from April 2-5.

The most eagerly anticipated study being presented at the
meeting will compare death rates in high-risk patients from
open heart valve replacement surgery to death rates for those
who get the Edwards Sapien system for transcatheter aortic
valve implantation, or TAVI.

Doctors have said there may be more than 100,000 patients
in the United States whose valve disease is either not being
addressed, or who cannot tolerate open heart surgery, who may
eventually be eligible for the TAVI approach.

The Sapien valve is threaded through the arteries to the
heart via a catheter inserted either in the femoral artery in
the groin or through a small incision between the rib cage,
avoiding the need for open-heart surgery in which the ribs are
sawed open, the heart is stopped and a new valve is sewn in.

Expectations are running high for the Edwards system, but
doctors will also be looking for evidence of whether it raises
the risk for stroke.

Results from the study called Partner will be used to seek
U.S. approval, expected later this year, for the Edwards system
that will eventually compete with a similar system being
developed by Medtronic Inc’s (MDT.N: Quote, Profile, Research) CoreValve unit.

Edwards shares are up 9 percent since January in
anticipation of positive results from the heart valve trial.
(Graphic on Edwards Lifesciences, 2008-2011: Edwards share
gains outpace revenue gains. http://r.reuters.com/suw78r )

The device is expected to garner $216 million to 2012
sales, according to Wells Fargo, a significant addition for a
company forecast for total 2011 sales of $1.63 billion.
(Edwards Lifesciences animation shows how its valve system is
placed in the heart:
http://www.edwards.com/products/transcathetervalves/transfemoralanimation.htm?SapienTHVPost=1 )

DEVICE-HEAVY MEETING

Pharmaceutical companies have increasingly turned their
attention to cancer, autoimmune diseases and specialty drugs,
since there is already a flood of blood pressure and
cholesterol treatments on the market.

As a result, there are fewer important drug studies at ACC
this year than perhaps at any previous meeting.

Other high-profile studies at the device-heavy meeting will
look at the safety and effectiveness of the next generation of
heart stents being tested by Medtronic, Boston Scientific Corp
(BSX.N: Quote, Profile, Research) and Abbott Laboratories. (ABT.N: Quote, Profile, Research)

Abbott will also have two-year data on its MitraClip to
demonstrate the durability of its minimally invasive technique
for repairing leaky heart valves.

One area of remaining hot competition in new drug
development is blood thinners that aim to replace warfarin and
may become alternatives to other drugs used to prevent blood
clots and strokes.

Xarelto, from Bayer (BAYGn.DE: Quote, Profile, Research) and Johnson & Johnson
(JNJ.N: Quote, Profile, Research), will be featured in a trial that compares the pill’s
ability to prevent blood clots in the leg and lung that occur
in hospitalized patients with that of the widely used
injectable Sanofi-Aventis (SASY.PA: Quote, Profile, Research) drug Lovenox.

Wells Fargo said a successful trial could open up a market
opportunity of $1.2 billion to $2.8 billion for Xarelto.

But Edwards is expected to steal the spotlight with
cardiologists.

In September, the company presented data from another arm
of the study that showed transcatheter valve recipients who
were too elderly and sick to endure surgery fared far better
than those who received standard drug treatment.

The data being presented at ACC is intended to show that
the transcatheter approach in patients with aortic stenosis is
as good as surgery in high-risk patients deemed able to endure
surgery.

“Positive data would significantly expand the patient
population … and support both approval of, and a broader
label for the Sapien valve in the United States,” William Blair
analyst Ben Andrew said in a research note.
(Reporting by Debra Sherman, Bill Berkrot and Ransdell
Pierson; Editing by Michele Gershberg and Matthew Lewis)

PREVIEW-All eyes on Edwards heart valve at medical meeting