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Abbott (ABT) Gets FDA Nod for Amplatzer Talisman System

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  • ABT
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Abbott Laboratories ABT recently received FDA approval for its Amplatzer Talisman PFO Occlusion System to treat patent foramen ovale (PFO) patients at risk of recurrent ischemic stroke. The next-generation Talisman system builds on the company’s industry-leading Amplatzer PFO Occluder.

A PFO may allow blood clots to pass from the right side of the heart to the left, from where they can travel to the brain, leading to a stroke. PFO closure is supported by extensive clinical trial data and the latest guidance from industry organizations as an essential treatment option for reducing the risk of recurrent stroke in patients.

Per management, the Talisman system enhances the efficiency and effectiveness of the PFO occlusion procedure. This system represents the company’s commitment to advance innovation in market-leading heart devices to enable people to live better lives through better health.

The recent FDA authorization for Amplatzer Talisman PFO Occlusion System will likely bolster Abbott's structural heart business.

Few Words on Talisman System

With the addition of the new 30mm offering, the Talisman system offers the broadest range of PFO occluder sizes in the United States. Further, all Talisman PFO occluders come pre-attached to the delivery cable, which reduces preparation time ahead of the procedure and makes it easier to use. The Talisman is fully recapturable and repositionable to ensure optimal placement. The system enables doctors to treat a wide range of patient anatomies.

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Zacks Investment Research

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Notably, the FDA cleared the Amplatzer Talisman Delivery Sheath used to deliver the occluder during implantation.

Industry Prospects

Per a report published in PR Newswire, the PFO Closure Devices market is expected to see a CAGR of 3.1% in the seven major markets (7MM) by 2026. Factors driving the market include increasing prevalence of PFO cases, growing preference for minimally-invasive procedures which are safe and technically feasible, and rising patient preferences for less-time-consuming procedures across the 7MM.

Per company data, about one in four people have a PFO, where the foramen ovale stays open or is "patent." However, physicians can opt for occlusion (or closure) of the PFO through a minimally-invasive procedure utilizing treatments like the Talisman system to reduce the risk of another stroke in patients who have already suffered a stroke due to their PFO.

Given the market prospects, the recent FDA approval for Abbott’s Amplatzer Talisman PFO Occlusion System seems well-timed.

Notable Developments

Abbott engaged in several significant developments in September 2021.

The company announced the receipt of FDA approval for its Epic Plus and Epic Plus Supra Stented Tissue Valves to enhance treatment options for aortic or mitral valve disease patients. These devices are the latest advancements in the company’s Epic surgical valve platform. These devices include innovations that make valve implantation and future cardiac interventions easier.

The company also received FDA approval for its Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat symptomatic, severe aortic stenosis patients at high or extreme risk for open-heart surgery. When placed inside a patient's natural valve, the Portico helps promote optimal blood flow (hemodynamics). The company continues to offer the industry's most comprehensive portfolio of structural heart solutions in the United States with the latest Portico approval.

The company acquired Walk Vascular, LLC, a commercial-stage medical device company with a minimally-invasive mechanical aspiration thrombectomy system intended for peripheral blood clot removal. This acquisition expands Abbott’s existing endovascular product portfolio by adding Walk Vascular's peripheral thrombectomy systems. However, the financial terms of the acquisition were kept under wraps.

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 6.4% compared with the industry’s 5.7% growth.

Zacks Rank and Key Picks

Currently, Abbott carries a Zacks Rank #4 (Sell).

A few better-ranked stocks from the broader medical space include Horizon Therapeutics Public Limited Company HZNP, Vertex Pharmaceuticals Incorporated VRTX and AMN Healthcare Services Inc AMN, each carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Horizon Therapeutics has a long-term earnings growth rate of 16.3%.

Vertex Pharmaceuticals has a long-term earnings growth rate of 9.8%.

AMN Healthcare a long-term earnings growth rate of 10.5%.


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Abbott Laboratories (ABT) : Free Stock Analysis Report

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