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Abbott's (ABT) Portico With FlexNav System Gets FDA Approval

Abbott Laboratories ABT recently announced the receipt of the FDA approval for its Portico with FlexNav transcatheter aortic valve replacement (“TAVR”) system. With the FDA approval of Portico, Abbott offers the industry's most wide-ranging portfolio of structural heart solutions in the United States.

The recent approval is expected to expand the company’s structural heart customer base within the Medical Device arm.

The Device

The Portico with FlexNav TAVR system is intended to treat people with symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery. In the United States, for people suffering from aortic stenosis and unable to undergo surgery, the Portico with FlexNav system provides a safe and effective treatment option.

More on the News

Aortic stenosis is one of the most frequent and life-threatening heart valve diseases. It happens when the aortic valve's opening narrows and restricts blood flow from the left ventricle to the aorta. Patients can experience breathlessness, chest pressure or tightness, fainting, palpitations, fatigue, and heart murmurs, which can eventually lead to heart failure.

Portico is a self-expanding TAVR valve with intra-annular (within the native valve) leaflets that help offer optimal blood flow (hemodynamics) when positioned inside a patient's natural valve. This replacement valve also preserves access to the vital coronary arteries for potential coronary interventions.

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The Portico device is implanted using Abbott's FlexNav delivery system, which features a slim design to hold different patient anatomies and small vessels, and enhance flexibility, ease of tracking and accuracy of valve placement.

Significance of the Approval

Per Abbott’s management, with the approval of the TAVR therapy in the United States, physicians can now have access to an even more robust set of solutions to treat structural heart disease. The latest introduction of Portico with FlexNav system marks another milestone for Abbott to progress with the aim to restore health and improve quality of life.

With this newest advancement in the TAVR system, Abbott continues to provide the industry's leading structural heart solutions portfolio, which includes innovative, minimally invasive therapies to repair or replace diseased or damaged heart valves or close openings in the heart.

Industry Prospects

Per a report by Market Data Forecast, the global transcatheter aortic valve replacement market is projected to grow from $3.06 billion in 2021 to $7.14 billion by 2026 at a CAGR of 18.5%.

The rising number of patients across the globe suffering from cardiovascular diseases such as heart failures, coronary artery diseases and hypertension, are the factors driving the market.

Recent Developments

In September 2021, Abbott presented late-breaking data from the Amulet Left Atrial Appendage (“LAA”) Occluder IDE trial comparing the company's Amplatzer Amulet LAA Occluder with Boston Scientific’s BSX Watchman device to treat people with atrial fibrillation (AFib) at a high risk of stroke. The result demonstrated that Amulet Occluder was better in LAA closure and non-inferior on safety and effectiveness endpoints as compared to the Watchman device.

In August 2021, Abbott released favorable data from its GUIDE-HF clinical trial on its small implantable pulmonary pressure sensor, CardioMEMS HF System. Adjusting for the impact of COVID-19, the study data shows that in a broad range of patients, there has been a strong decline in the composite endpoint of heart failure hospitalizations, emergency visits and death.

Price Performance

Shares of the company have gained 19.2% in a year’s time compared with the industry’s rise of 11.4%.

Zacks Rank and Key Picks   

Currently, Abbott carries a Zacks Rank #3 (Hold).

A couple of better-ranked stocks from the broader medical space are Envista Holdings Corporation NVST and Biolase, Inc. BIOL, each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.

Envista Holdings has an estimated long-term earnings growth rate of 27%.

Biolase has a projected long-term earnings growth rate of 15%.


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Abbott Laboratories (ABT): Free Stock Analysis Report
 
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