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Abbott (ABT) Receives CE Mark for Latest Navitor TAVI System

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Abbott Laboratories’ (ABT - Free Report) structural heart line has received a major boost with the latest European regulatory approval for the company’s newest-generation transcatheter aortic valve implantation (“TAVI”) system – Navitor. Per the company, with receipt of the CE mark, the minimally invasive device is now available in Europe to treat people with severe aortic stenosis who are at high or extreme surgical risk.  

The Navitor TAVI system is the latest addition to the company's comprehensive structural heart transcatheter portfolio using Abbott's FlexNav delivery system which offers physicians and patients less-invasive options to treat heart diseases.

The approval will fortify Abbott’s structural heart portfolio of minimally invasive offerings by providing new options and developments to treat a life-threatening heart condition.

More on Navitor TAVI System

The Navitor device is paired with Abbott's FlexNav delivery system, which received CE mark in 2020 and offers a slim design with a low TAVR delivery system profile, allowing treatment of people with vessels as small as 5 mm. The device helps in streamline and simplifying TAVI procedures for physicians, enabling better valve placement and performance for improved patient outcome.

Significance of the Approval

With an aging world population and the projection for aortic stenosis cases to double in Europe and the United States in the next few years, the need for innovative, minimally invasive solutions is significant.  Navitor helps address challenges physicians sometimes face in current TAVI systems in cases of complex patient anatomies. These challenges can otherwise lead to potential complications.  

Aortic stenosis is a medical condition which restricts blood flow through the aortic heart valve to the rest of the body, which can lead to heart failure, and in certain cases, sudden cardiac death. Navitor TAVI System will serve as a less-invasive alternative to surgical aortic valve replacement that can reduce symptoms and enhance the lives of patients with this debilitating condition.

Industry Prospects

Per a report by Grand View Research, the global aortic valve replacement device market size was $5.81 billion in 2017 and is expected to grow at CAGR of 11.1% by 2025. Growing prevalence of valvular diseases, such as aortic stenosis & aortic regurgitation, and increasing preference for minimally invasive surgeries are among key trends driving the market.

Recent Developments Within Structural Heart

In April 2021, Abbott received latest European regulatory approval for the company’s next-generation TriClip device. Per the company release, this first-of-its-kind minimally invasive transcatheter tricuspid valve repair system, called TriClip G4, received CE mark to treat tricuspid regurgitation.

During the first quarter, Structural Heart portfolio sales were up mid-teens with growth contributions coming from several products within the innovative portfolio, including MitraClip, TriClip, Portico and others.

Price Performance

Shares of the company have gained 29.3% in a year’s time compared with the industry’s growth of 15.5%.

Zacks Rank and Key Picks

Currently, the company carries a Zacks rank #3 (Hold).

A few better-ranked stocks from the broader medical space are National Vision Holdings, Inc. (EYE - Free Report) , Owens & Minor, Inc. (OMI - Free Report) and Envista Holdings Corporation (NVST - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.

Owens & Minor has a projected long-term earnings growth rate of 15%.

National Vision has a projected long-term earnings growth rate of 12%.

Envista Holdings has an estimated long-term earnings growth rate of 26%.

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