Integra LifeSciences (IART) announced that it has received U.S. FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System, for use in cardiac surgery.
This clearance expands the system's indications to include debridement of unwanted soft tissue during procedures such as valve replacement and repair.
The CUSA Clarity system is already approved for use in neurosurgery, orthopedic, plastic and reconstructive, thoracic, laparoscopic, gynaecological, and liver surgeries, where fragmentation, emulsification and aspiration of soft and hard tissue is desirable.
The recent FDA clearance for cardiac indications marks a significant milestone, enabling surgeons to apply ultrasonic aspiration in delicate cardiovascular procedures such as valve replacement and repair.
The FDA clearance reflects sufficient safety and performance data supporting the system's use in cardiac applications.
Integra will showcase the CUSA Clarity system at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11-12, 2025, highlighting its expanded role in advanced cardiac care.
IART has traded in the range of $10.87 - $27.13 in the last 1 year. The stock closed yesterday's trading at $12.33, up 1.23%.
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