FDA Clears CUSA Clarity Ultrasonic Surgical Aspirator for Cardiac Procedures

Published On 2025-11-21 03:45 GMT | Update On 2025-11-21 07:03 GMT

Integra LifeSciences has received 510(k) clearance from the U.S. Food & Drug Administration for its CUSA Clarity Ultrasonic Surgical Aspirator System to be used in cardiac surgeries, specifically for the debridement of unwanted tissue in procedures such as valve replacement and repair.

The system-already indicated for a range of surgical specialties like neurosurgery, orthopedic, plastic/reconstructive, thoracic, laparoscopic, gynecological, and hepatic surgeries- now expands its intended use to include cardiac surgery.

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 December 11 and 12, 2025.

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

FDA Clears CUSA Clarity Ultrasonic Surgical Aspirator for Cardiac Procedures

Similar News

Limited Torniquet application tied to superior pain scores in early post-operative period in TKR surgeries: study

Optimal Mesh Weight Identified to Reduce Reoperation Risk After Laparoscopic Hernia Repair: JAMA

Asymptomatic Kidney Stones Don't Raise Post-Surgery Risks After Radical Cystectomy: Study

Periodontal Regeneration vs Dental Implants: Study Finds Similar Survival but Higher Implant Complications

Individualized MAP Targets Offer No Benefit Over Standard BP Management After Major Abdominal Surgery: JAMA

Arm or Leg? Both Aerobic Training Approaches Improve Walking in PAD: RCT Finds

Tranexamic acid Cuts need for blood transfusions during hospitalization for non-cardiac surgery: Study

Needling vs Non-Needling Therapies: New Meta-Analysis Reveals Most Effective Treatment for TMD Pain