AtriCure, Inc. ATRC recently announced the receipt of an expanded indication for the AtriClip in CE-marked countries in Europe. The product is now indicated for use in patients at high risk of thromboembolism for whom left atrial appendage (LAA) exclusion is warranted.
The European Commission's expanded indication is based on AtriCure's clinical findings that patients who are at high risk of thromboembolism can experience fewer strokes with AtriClip.The company expects significant growth potential for the use of mechanical appendage closure.
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The LAA is a major source of blood clots in patients with atrial fibrillation (Afib), and the AtriClip device series represents a novel approach to electrically isolate, exclude, and ultimately remove the LAA in the course of heart surgery.
More than 85 peer-reviewed papers on the short- and long-term safety and effectiveness of AtriClip devices have been published since the device initially went into use in 2007. This amounts to more than 11,000 patients who were investigated in various regions. The ArtiClip devices, which are already driving revenues in the United States, are likely to generate more international revenues after the expansion of the CE- Mark indication.
In July 2024, AtriCure announced that it had received regulatory approval from the National Medical Products Administration of China to market and sell several models of its AtriClip LAA Exclusion System.The company is likely to work closely with Chinese regulatory authorities to facilitate the introduction of additional innovative products in the future. This approval is expected to expand AtriCure's business globally and generate additional revenues.
Industry Prospects
Per a report by Grand View Research, the global atrial fibrillation market size was estimated to be $22.4 billion in 2022 and is expected to witness a growth rate of 10.1% from 2023 to 2030.
The increasing prevalence of AFib and growing awareness about the condition are expected to drive the market. Factors such as the aging population, lifestyle changes, and the surge in chronic illnesses such as obesity and diabetes are contributing to the rising incidence of atrial fibrillation.
Product Portfolio Expansion
AtriCure, a leading innovator in surgical treatments and therapies for Afib, LAA management and post-operative pain management, boasts a strong product portfolio and plans to expand to improve patient care in the future.
In April, AtriCure launched the cryoSPHERE+ cryoablation probe, leveraging new insulation technology to reduce freeze times by 25% versus AtriCure's legacy cryoSHPERE device. The cryoSPHERE+ received FDA 510(k) clearance for temporarily blocking pain by ablating peripheral nerves in adult patients and by ablating intercostal nerves under direct visualization in adolescent patients.
The company is likely to advance several clinical initiatives in the second half of 2024, including its LeAAPS stroke reduction trial and introduce new products across its markets, with two cryoSPHERE probes to reduce freeze times and the most advanced, smallest profile AtriClip device.
Price Performance
In the year-to-date period, ATRC's shares have plunged 31.8% against the industry's rise of 9.1%. The S&P 500 has gained 17.8% in the same time frame.
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Zacks Rank and Stocks to Consider
ATRC carries a Zacks Rank #3 (Hold) at present.
Some better-ranked stocks in the broader medical space are Universal Health Service, Quest Diagnostics and ABM Industries. While Universal Health Service sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy).
Universal Health Service has an estimated long-term growth rate of 19%. UHS' earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.
Universal Health Service has gained 41.1% compared with the industry's 34.8% rise so far this year.
Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX's earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.
Quest Diagnostics shares have gained 3.7% so far this year compared with the industry's 10.2% rise.
ABM Industries' earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.
ABM's shares have risen 24.1% so far this year compared with the industry's 11.9% growth.
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