Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries
Integra LifeSciences Holdings Corporation (IART)
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Source: GlobeNewswire
PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, is pleased to announce the FDA 510(k) clearance for use of its CUSA® Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries. The recent clearance for specific cardiac indications encompasses the debridement of unwanted tissue in cardiac surgeries, including valve replacement and repair. In addition to cardiac surgery, the CUSA Clarity Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, such as neurosurgery, plastic and reconstructive surgery, orthopedic surgery, thoracic surgery, laparoscopic surgery, gynecological surgery, and liver resection and transplant surgery. “The utilization of CUSA Clarity for cardiac surgery marks the next pivotal expansion of the ultrasonic surgical aspirator sy
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