Abbott Labs' Mitra Clip Approved in the U.S. - Analyst Blog
Abbott Laboratories ( ABT ) received positive news when the U.S. Food and Drug Administration (FDA) approved its percutaneous valve repair system, MitraClip.
The FDA approved MitraClip device to treat patients with significant symptomatic degenerative mitral regurgitation (MR) who are at prohibitive risk of mitral valve surgery. Consequently, Abbott Labs will launch its MitraClip device immediately in the U.S.
We note that MitraClip is already approved in the Europe and parts of Asia and Latin America.
Meanwhile, Abbott Labs continues to evaluate the impact of MitraClip treatment on the progression of heart failure through two randomized trials - COAPT in the U.S. and RESHAPE-HF in Europe.
We note that the vascular business is an important part of Abbott Labs' product portfolio. The vascular business generated total sales of $2.2 billion in the first nine months of 2013, down 3.1% year over year.
For the third quarter, vascular sales were up 2.5% on an operational basis driven by continued share gains in international markets. Of the total vascular sales, approximately $384 million came from the sale of drug-eluting stents and the bioresorbable vascular scaffold (BVS) product portfolio.
The approval of MitraClip will strengthen Abbott Labs' vascular business which already has drug-eluting stent, Xience Xpedition and BVS Absorb, under its portfolio.
Moreover, the acquisition of privately-held IDEV Technologies has added SUPERA Veritas stent system to Abbott Labs' product portfolio.
The stent system is approved in Europe for treating blockages in blood vessels due to peripheral artery disease (PAD). Moreover, SUPERA Veritas is approved in the U.S. for the treatment of biliary strictures (narrowing of a bile duct) related to cancer.
Abbott Labs expects to increase sales in low single digits (excluding foreign exchange rates) in the fourth quarter of 2013.
We believe the launch of new products will help Abbott Labs to broaden its vascular business.
We remind investors that Abbott Labs became a diversified medical products company focusing on branded generic pharmaceutical, medical devices, diagnostic and nutritional businesses following the separation of its research-based pharmaceuticals business into a new company, AbbVie Inc. ( ABBV ), in Jan 2013.
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