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Abbott (ABT) Expands in Electrophysiology With New FDA Nod

Abbott's ABT catheter line of products advanced after it received regulatory approval. The company announced that its TactiFlex Ablation Catheter, Sensor Enabled has received FDA approval for treating people with abnormal heart rhythms like atrial fibrillation (AFib). The company claims this catheter to be the world’s first ablation catheter with a flexible tip and contact force technology.

The latest approval broadens the company’s electrophysiology business line.

In February, the company had received European CE Mark for TactiFlex Ablation Catheter, Sensor Enabled. This catheter is also approved for use in Japan, Africa and Australia.

More on the News

Patients with AFib often feel dizziness, chest pain and heart palpitations. AFib can even lead to stroke if left untreated. From a medical perspective, it is always better to address the issue as fast as possible.

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AFib is currently claimed to be the most common abnormal heart rhythm.

Abbott noted that using TactiFlex catheters can reduce procedure times and provide better safety compared to the company's previous-generation catheters.

The TactiFlex catheter is designed to be used together with Abbott's EnSite X EP System.  EnSite X is the company’s advanced heart mapping system enabling physicians to view and precisely identify areas in the heart that require ablation.

How TactiFlex is Superior to Other Catheters

According to Abbott, unlike other available catheters, the TactiFlex catheter is facilitated by a tip design with a laser-cut pattern. It flexes when in contact with the heart wall. This helps in directing fluid to the treated tissue, allowing more accurate positioning of the catheter. This in turn provides up to two-times higher stability in a beating heart, crucial for consistent therapy delivery.

In this regard, the company noted that the TactiFlex catheter generated strong clinical outcomes in the TactiFlex AF IDE study with more than 99% acute procedural success.

 

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Huge Market Prospect for TactiFlex

Per data provided by Abbott, over 37 million people globally live with AFib and this figure is expected to more than double by 2050. Further, an additional five million cases are diagnosed every year, indicating a growing health challenge requiring cutting-edge solutions.

In such a situation, we believe the latest regulatory approval in the United States is well-timed and strategic.

Latest Development

Abbott’s last-reported first quarter of 2023 organic sales growth, excluding COVID testing, increased 10%, led by double-digit growth in Medical Devices, Established Pharmaceuticals Division (EPD) and Nutrition. Within EPD, sales increased 11% in the quarter led by strong performance in Brazil, China, and Southeast Asia and across several therapeutic areas, including cardiometabolic, gastroenterology, CNS and pain management.

Within Nutrition, sales increased more than 10%. In the United States, pediatric nutrition growth of more than 35% was driven by favorable year-over-year comparisons (lower sales in the first quarter of 2022 were due to a voluntary recall of certain infant formula products).

Within Diagnostics, excluding COVID testing, organic sales growth was led by mid to high single-digit growth in Core Lab, Rapid and Point of Care Diagnostics. Despite dull sales in China, Core Lab Diagnostics sales showed year-over-year improvement led by strong performance in the United States and Europe.

Within Medical Devices, sales grew 12.5% globally on an organic basis, including mid-teens growth in the United States and double-digit growth internationally. In Diabetes Care, sales of FreeStyle Libre grew more than 25% on an organic basis in the quarter, including approximately 50% growth in the United States and mid-teens growth internationally.

Share Price Performance

Over the past year, Abbott has been outperforming the industry it belongs to. The stock has lost 5.3% compared with the industry’s 29.6% fall.

Zacks Rank & Key Picks

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

Some better-ranked stocks in the broader medical space are Addus Homecare Corporation ADUS, Merit Medical Systems, Inc. MMSI and Davita Inc DVA.

The Zacks Consensus Estimate for Addus Homecare’s 2023 earnings indicates 10.9% year-over-year growth. The Zacks Consensus Estimate for ADUS’s 2023 earnings has moved 0.5% north in the past 30 days.

Addus Homecare has a long-term estimated growth rate of 11.8%.It currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Merit Medical reported first-quarter 2023 adjusted EPS of 64 cents, beating the Zacks Consensus Estimate by 16.4%. Revenues of $297.6 million surpassed the Zacks Consensus Estimate by 5.9%. It currently carries a Zacks Rank #2.

Merit Medical has a long-term estimated growth rate of 11%. MMSI’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 20.2%.

DaVita, carrying a Zacks Rank #2 at present, has a long-term estimated growth rate of 14.6%. DVA’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 17.3%.

DaVita has lost 1.9% compared with the industry’s 18% decline over the past year.

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