Insera血栓抽吸系统Clear获FDA 510(k)许可：清除外周动静脉新鲜软血栓、三种抽吸模式
Insera Therapeutics 11月12日宣布，其 Clear 抽吸系统已获美国食品药品管理局（FDA）510(k)许可，用于清除外周动脉与静脉系统内的新鲜、柔软栓子与血栓。
该系统由一台可重复使用的抽吸泵与一次性组件组成，提供三种抽吸模式，供医生按血栓位置与形态选用。许可所针对的部位为外周动静脉系统，不包括冠状动脉与脑血管。
抽吸取栓是急性肢体缺血与深静脉血栓等疾病的常用介入手段之一。Insera 表示，该系统现可在美国临床使用。（来源：Insera Therapeutics）
Insera's Clear Aspiration System Cleared by the FDA: Removes Fresh, Soft Clots From Peripheral Arteries and Veins, With Three Aspiration Modes
Insera Therapeutics announced on November 12 that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Clear aspiration system, intended for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems.
The system combines a reusable aspiration pump with single-use components and offers three aspiration modes, allowing physicians to match the approach to clot location and morphology. The clearance covers the peripheral arterial and venous systems and does not extend to the coronary or cerebral vasculature.
Aspiration thrombectomy is one of the established catheter-based options for conditions such as acute limb ischemia and deep vein thrombosis. Insera said the system is now available for clinical use in the United States. (Source: Insera Therapeutics)
来源：Insera Therapeutics
发布：GSM·美国（发布链接）
图片来源：图片来源：Wikimedia Commons「A cardiac catheterization procedure in the Naval Medical Center San Diego hospital’s cardiac catheterization laboratory - 50428593407.jpg」（Navy Medicine 摄，Public domain），图中为介入导管实验室 Image: Wikimedia Commons "A cardiac catheterization procedure in the Naval Medical Center San Diego hospital’s cardiac catheterization laboratory - 50428593407.jpg" (by Navy Medicine, Public domain)
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