Integra LifeSciences Receives FDA 510(k) Clearance for CUSA Clarity Ultrasonic Surgical Aspirator System in Cardiac Surgery
核心洞察
Integra LifeSciences received FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System (搜索) for cardiac surgeries, including valve replacement and repair procedures.
The clearance specifically encompasses debridement of unwanted tissue in cardiac surgeries, expanding the system's indications beyond its existing approvals for neurosurgery and other surgical specialties.
The CUSA Clarity system is designed for fragmentation, emulsification and aspiration of soft and hard tissue across multiple surgical disciplines including orthopedic, thoracic, and liver transplant surgery.
Integra LifeSciences Holdings Corporation (搜索) announced on November 11, 2025, that it has received FDA 510(k) clearance for the use of its CUSA Clarity Ultrasonic Surgical Aspirator System (搜索) in cardiac surgeries. The clearance specifically covers debridement of unwanted tissue in cardiac procedures, including valve replacement and repair operations.
Expanded Surgical Applications
The CUSA Clarity Ultrasonic Surgical Aspirator System (搜索) was previously indicated for surgical procedures requiring fragmentation, emulsification and aspiration of soft and hard tissue, including bone. The system's existing approvals cover 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 (搜索) division. "As one of the leaders in the industry, this milestone strengthens our ability to deliver advanced surgical solutions to support restoring patients' lives."
Technology Platform
The CUSA Clarity system utilizes ultrasonic technology to fragment and aspirate tissue during surgical procedures. The device's capability to handle both soft and hard tissues makes it versatile across multiple surgical specialties, with the cardiac surgery clearance representing a significant expansion of its clinical applications.
Market Presence
Integra LifeSciences plans to showcase the CUSA Clarity Ultrasonic Surgical Aspirator System (搜索) at the American Association for Thoracic Surgeon (搜索) Mitral Valve Conclave in New York City on December 11 and 12, 2025. This presentation will highlight the system's newly approved cardiac surgery capabilities.
The company positions itself as a global medical technology leader focused on neurosurgery and tissue reconstruction, describing its portfolio as consisting of "highly differentiated, gold-standard technologies" trusted by healthcare professionals.