) recently announced that the US Food and Drug Administration
(FDA) Circulatory System Devices Panel of the Medical Devices
Advisory Committee has voted in favor of the company's device
The committee acknowledged that the benefits of treatment with
the MitraClip device considerably outweighed the risks in
patients suffering from major symptomatic mitral regurgitation
8 votes out of nine were in favor of the device being
reasonably safe. On the subject of efficacy, 4 votes were in
favor while 5 votes were against the same.
The favorable recommendation was based on positive data from
EVEREST II, EVEREST II High Risk and REALISM STUDIES wherein
Mitra Clip demonstrated positive results.
These patients were at a high risk for open mitral valve
surgery. The device is delivered to the heart through a blood
vessel in the leg (the femoral vein). The MitraClip system aims
to bring down MR by clipping together the leaflets of the mitral
valve so that the heart can pump blood in a more efficient
The MitraClip system received CE mark (mandatory confirmation
for products placed in the European market) in 2008 and is
marketed in Europe and in parts of Asia and Latin America.
Abbott expects that the panel's opinion will positively impact
FDA's decision when it decides on the approval of the MitraClip
for the treatment of significant MR in the US later in 2013.
Meanwhile, Abbott is working on boosting its vascular products
portfolio and expects to launch several products in the next five
years. The company intends to work on increasing international
MitraClip sales and developing ABSORB, its bioresorbable vascular
scaffold (BVS) device.
Abbott is also focusing on strengthening its drug eluting
product portfolio, powered by the launch of Xience Xpedition
drug-eluting stent in Europe in Aug 2012 and in the US in Jan
2013. Abbott expects to launch Expedition in Japan in mid-2013
and market products in the Xience family.
Abbott currently carries a Zacks Rank #3 (Hold). Right now,
pharma companies that look attractive include
Furiex Pharmaceuticals Inc.
). All three carry a Zacks Rank #2 (Buy).
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