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)
Source: Insera Therapeutics
Published by GSM · USA (original Chinese edition)
Photo: 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)
