LeMaitre Vascular's Artegraft, a biologic graft used in AV access and peripheral bypass procedures, received its MDR CE Mark on April 29, 2025. This regulatory approval is a significant milestone, as it allows the company to commence the European launch of this key product. Artegraft is LeMaitre's largest U.S. product, having generated $37 million in U.S. sales in 2024.
The CE Mark is a mandatory conformity marking for products sold within the European Economic Area, indicating that Artegraft meets the stringent health, safety, and environmental protection standards of the European Union. This approval provides LeMaitre Vascular with a substantial opportunity to expand its market presence and revenue streams in Europe. The European launch is set to begin presently, capitalizing on this regulatory achievement.
The introduction of Artegraft into the European market is a major growth catalyst for LeMaitre Vascular, leveraging a product that has already proven highly successful in the United States. This strategic expansion into a new, large market segment is expected to contribute significantly to the company's international sales and overall financial performance.
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