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June 5, 2025

Penumbra’s Ruby XL System Cleared by FDA for Peripheral Embolization

June 5, 2025—Penumbra, Inc. announced the FDA clearance and launch of the Ruby XL system, part of the company’s Ruby portfolio of peripheral embolization products.

According to Penumbra, the Ruby XL, which features a long, large, and soft coil, is designed to help physicians achieve more efficient vascular embolization, potentially reducing radiation exposure and optimizing outcomes, especially in large-vessel and high-flow embolization.

Penumbra noted that the Ruby XL system introduces three technologies—Ruby XL, POD XL, and Packing Coil XL. These three elements can be delivered through a 0.035-inch+ diagnostic catheter. They have a 0.030-inch primary diameter and are designed for procedural efficiency. The coils offer volumes up to 40 mm in size and are available in extended lengths up to 70 cm, stated the company.

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