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Abbott Receives European Nod for Pediatric Heart Devices

Zacks Equity Research

Abbott Laboratories ABT announced receiving approvals for two life-saving pediatric devices — the Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder — in Europe. The devices have received the CE Mark, and are currently available in Europe and other countries that recognize CE Mark.

The new treatments are already available in the United States, and offer hope to young pediatric patients and their families when no other appropriate treatment options are available.

With the latest offerings to treat critical cases of babies and children born with common congenital heart defects, Abbott aims to improve its footprint in the global pediatric mechanical heart valve market.



Few Words on the Devices

The Masters valve is much smaller in size (15mm) and the company claims that it is the world's smallest mechanical heart valve. Mechanical heart valves are required in cases, where the heart valve tissues are significantly deformed or are damaged beyond repair. The mechanical valve resembles a healthy heart valve and regularizes blood flow through the heart with each heartbeat.

Amplatzer Piccolo (approved in the United States in January 2019) is a self-expanding wire-mesh device, which is inserted through a small incision in the leg and guided through vessels to the heart, where it is placed to seal the opening.

With Amplatzer Piccolo, most of the critically ill premature babies in the neonatal intensive care unit can be taken off the artificial respirator support soon after the minimally invasive procedure.

Significance of the Devices

Every year, around 36,000 babies are born with congenital heart defects (“CHD”) in the European Union alone. The Masters valve is expected to help doctors treat babies and toddlers, who require mitral or aortic heart valve replacement.

The Amplatzer Piccolo, which is smaller than a pea, can even be implanted in babies, who weigh less than a kilogram, to treat patent ductus arteriosus (PDA), which is a potentially life-threatening opening in the heart. Abbott believes that this device is the world’s first medical device that can be implanted even in premature babies.

Why the Approval is Important

To date, the only option available to doctors for treating issues of pediatric heart valve was to replace the damaged valve with a range of larger-sized valves. This could result in future complications.

Abbott believes that the two devices can help infants and children to live their fullest life.

With these approvals, the company aims to provide a dependable and corrective treatment solution, and subsequently healthy life to patients, who may be non-responsive to medical management and also pose an increased risk of corrective surgery. It believes that with these technological advancements, doctors can treat structural heart disease in pediatric patients who have limited options.

Given the huge potential for offering treatments to infants, these approvals have come at just the right time.

Industry Prospects

Per a report by Grand View Research, the global structural heart devices market size was valued at approximately $4.1 billion in 2016. It is estimated to witness a CAGR of 9.15% between 2018 and 2025. The market is mainly driven by the large prevalence of target diseases.

Given the increasing cases of structural heart diseases, the company expects to hold on to the ongoing growth momentum in its structural heart business.

Recent Developments

Abbott announced the launch of its TRILUMINATE Pivotal trial in September 2019. The trial will assess the safety and effectiveness of the company's TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR).

In July, Abbott received the FDA nod for its next-generation version of MitraClip heart valve repair device used to repair a leaky mitral valve without open-heart surgery. Also, the company initiated an important clinical study of its Tendyne Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of mitral regurgitation in the United States. The trial will gauge the safety and usefulness of the treatment in patients, who are suffering from mitral regurgitation (MR), known as a leaky heart valve.

Share Price Performance

The company has gained 22% in the past year against the industry’s decline of 0.3%. The S&P 500 index has rallied 2.3% during the same period.

Zacks Rank & Stocks to Consider

Currently, Abbott carries a Zacks Rank #3 (Hold). A few better-ranked stocks from the broader medical space are Baxter International Inc. BAX, GW Pharmaceuticals PLC GWPH and Neurotrope, Inc. NTRP.

Baxter, with a Zacks Rank #2 (Buy), has a projected long-term earnings growth rate of 12.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GW Pharmaceuticals estimates third-quarter earnings growth rate to be 72.9%. It currently sports a Zacks Rank #1.

Neurotrope, with a Zacks Rank #2, has a projected third-quarter earnings growth rate of 27.7%.

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