FDA Grants 510(k) Clearance to Ultrasonic Surgical Aspirator System for Cardiac Surgeries

 Nov. 11, 2025 -— Integra LifeSciences Holdings Corp. has announced 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 system’s breadth of indications,” said Mike McBreen, executive vice president and president of Integra’s Codman Specialty Surgical division. “As one of the leaders in the industry, this milestone strengthens our ability to deliver advanced surgical solutions to support restoring patients’ lives.”

Integra LifeSciences will spotlight the CUSA Clarity Ultrasonic Surgical Aspirator System at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on Dec. 11 and 12, 2025.

For more information, please visit www.integralife.com.