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Abbott MitraClip G4 Gets FDA Nod, Valve Repair Options Expand

Zacks Equity Research

Abbott Laboratories ABT recently announced FDA approval for its latest version of MitraClip heart valve repair device to treat mitral regurgitation (MR). With the approval for the fourth-generation MitraClip device, MitraClip G4, the company aims to establish a system that would help physicians deliver personalized, patient-focused therapy as well as more features that can treat both primary and secondary MR.

The regulatory breakthrough will boost Abbott’s existing structural heart business.

More About MitraClip G4

The MitraClip system is the first and only transcatheter mitral valve therapy which claims to provide safer and more durable clinical outcome.

It offers physicians an expanded range of clip sizes, a substitute leaflet grasping feature and real-time procedure evaluation for treating mitral valve disease. MitraClip G4 also provides independently-controlled grippers that help physicians grasp one or both leaflets during the procedure, known as Controlled Gripper Actuation.

Equipped with an enhanced catheter, MitraClip G4 facilitates integrated real-time continuous left atrial pressure monitoring during implant. The feature enables doctors to use a commercially-available pressure monitor integrated into the MitraClip catheter to continually monitor and verify MR reduction during the implant procedure.

Abbott Laboratories Price


Abbott Laboratories Price
Abbott Laboratories Price

Abbott Laboratories price | Abbott Laboratories Quote

Market Prospects

Per Allied Market Research, the transcatheter mitral valve repair & replacement market was valued at $324 million in 2016, and is anticipated to reach a worth of $1.87 billion, at a CAGR of 30.0% from 2017 to 2023. Hence, the FDA approval comes at an ideal time.

Recent MitraClip Developments

The MitraClip device repairs leaky mitral valves without the need for open-heart surgery. To date, MitraClip has been used in the treatment of more than 80,000 people all over the world suffering from primary and secondary MR and is supported by the industry's most extensive body of clinical evidence, including the latest results from the COAPT Trial.

This system has been commercially available in the United States since 2013 and in Europe since 2008. Of late, Abbott has been investing in several developments pertaining to the MitraClip.

MitraClip was approved in the United States in 2013 for primary MR patients. In March 2019, the FDA approved MitraClip for secondary MR patients based on positive outcomes from the COAPT Trial, which evaluated the effectiveness of MitraClip in the treatment of secondary MR.

The COAPT trial demonstrated a 47% relative reduction in hospitalization and a 38% relative drop in mortality. Both primary and secondary MR patients are expected to benefit from MitraClip therapy based on this expanded indication for MitraClip. Since the initial approval, Abbott has launched two newer generations, G2, G3 and now G4, to upgrade the quality of patient care.

Price Performance

In the past year, Abbott has rallied 33.5% versus the industry’s 6% rise.

Zack Rank and Key Picks

Abbott currently curries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space are Teleflex Inc. TFX, Penumbra PEN and NuVasive Corporation NUVA. While Teleflex currently carries a Zacks Rank #2 (Buy), the other two have a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Teleflex’s long-term earnings growth rate is expected at 13.7%.

Penumbra’s long-term earnings growth rate is projected at 21.5%.

NuVasive’s long-term earnings growth rate is expected to be 11.9%.

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