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Abbott (ABT) Gets FDA Approval for Expanded Use of MitraClip

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Abbott Laboratories ABT recently announced that its flagship platform — MitraClip transcatheter clip-based device — has received FDA approval for the treatment of secondary or functional mitral regurgitation (“MR”).

The approval closely follows Abbott’s favorable results from a two-year clinical trial called COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy). The study showed that Abbott’s MitraClip performs better than any traditional treatment for functional MR available in the market.

This regulatory go-ahead is expected to strengthen the company’s Structural Heart business.

MitraClip — a Strong Growth Driver

MitraClip is the world's first minimally-invasive mitral valve repair device. It provides instant symptom relief and ensures swift discharge of patients.

For investors’ notice, MitraClip has been a significant top-line contributor. In fact, the platform registered year-over-year growth of about 30% in the fourth quarter of 2018.

In 2013, MitraClip was approved as a repair device for primary MR.

Structural Heart Unit Strengthens

Abbott's structural heart business is a leader in occlusion devices that treat or close openings in the heart caused by congenital defects.

Abbott Laboratories Price

Abbott Laboratories Price | Abbott Laboratories Quote


The company witnessed double-digit growth in the business in the fourth quarter of 2018. Growth was driven by several product areas, including AMPLATZERPFO Occluder and MitraClip.

Market Prospects

Per Allied market research, the global market for transcatheter heart valve replacement and repair is projected to reach a worth of $8.13 billion, at a CAGR of 13.8% in the 2017-2025 period.

About 6.5 million people suffer heart failure in the United States. Abbott expects MitraClip to reach a market worth of $4 billion in the Unites States.

Favorable Regulatory Tidings

In January 2019, Abbott received FDA approval for its TactiCath Contact Force Ablation Catheter, which has been designed for the treatment of atrial fibrillation. The FDA also approved Abbott’s minimally-invasive transcatheter for the treatment of premature babies and newborns with an opening in their heart.

Last October, Abbott’s HeartMate 3 heart pump was approved by the FDA for patients with advanced heart failure.

Just a month prior to that, real-world research proved that Abbott’s Portico transcatheter aortic valve was equipped to treat severe aortic stenosis.

Meanwhile, the Zacks Consensus Estimate for the company’s 2019 earnings per share is pegged at $3.20, reflecting a year-over-year increase of 11.1%. The same for revenues is pinned at $31.8 billion, indicating an increase of 4% year over year.

Zacks Rank & Key Picks

Abbott has a Zacks Rank of #3 (Hold). A few better-ranked stocks in the broader medical space are ABIOMED, Inc., ABMD, Varian Medical Systems, Inc. VAR and Masimo, Inc. MASI. Each of these stocks currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

ABIOMED’s long-term earnings growth rate is expected at 27.67%.

Varian’s long-term earnings growth rate is projected at 8.00%.

Masimo’s long-term earnings are projected to grow 15.60%.

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