Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries

Core Insights - Integra LifeSciences Holdings Corporation has received FDA 510(k) clearance for its CUSA Clarity Ultrasonic Surgical Aspirator System for use in cardiac surgeries, specifically for debridement of unwanted tissue during valve replacement and repair [1][2][3] Company Overview - Integra LifeSciences is a global leader in medical technology, focusing on restoring lives through innovative solutions in neurosurgery and tissue reconstruction [4] - The company emphasizes its commitment to delivering advanced surgical solutions that enhance patient care [3][4] Product Applications - The CUSA Clarity Ultrasonic Surgical Aspirator System is also indicated for various surgical procedures beyond cardiac surgery, including neurosurgery, plastic and reconstructive surgery, orthopedic surgery, thoracic surgery, laparoscopic surgery, gynecological surgery, and liver resection and transplant surgery [2][3] Industry Impact - The expansion of the CUSA Clarity's indications to include cardiac surgery represents a significant milestone for the company, enhancing its position as a leader in the surgical technology industry [3] - The product will be showcased at the American Association for Thoracic Surgeon Mitral Valve Conclave in New York City on December 11 and 12, 2025, highlighting its importance in the surgical community [3]