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FDA Panel Favors Abbott's MitraClip

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Abbott Laboratories (ABT - Free Report) 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 MitraClip.

The committee acknowledged that the benefits of treatment with the MitraClip device considerably outweighed the risks in patients suffering from major symptomatic mitral regurgitation (MR).

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 manner.

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 Novo Nordisk (NVO - Free Report) , Furiex Pharmaceuticals Inc. and Abbvie Inc. .  All three carry a Zacks Rank #2 (Buy).

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