Integra LifeSciences Receives FDA 510(k) Clearance for Use of the CUSA® Clarity Ultrasonic Surgical Aspirator System for Cardiac Surgeries
Rhea-AI Summary
Integra LifeSciences (Nasdaq:IART) announced FDA 510(k) clearance for the CUSA® Clarity Ultrasonic Surgical Aspirator System for use in cardiac surgeries on Nov 11, 2025.
The clearance specifically covers debridement of unwanted tissue in cardiac surgeries, including use during valve replacement and repair. The system retains its broader indications for fragmentation, emulsification and aspiration of soft and hard tissue across specialties such as neurosurgery, orthopedic, thoracic, laparoscopic, gynecological, plastic/reconstructive, and liver resection/transplant surgery.
Integra will spotlight CUSA Clarity at the AATS Mitral Valve Conclave in New York City on Dec 11–12, 2025.
Positive
- FDA 510(k) clearance granted for cardiac surgical indications
- Clearance explicitly covers debridement for valve replacement and repair
- Broad multi-specialty indications already include neurosurgery, orthopedics, thoracic and liver surgery
- Device to be showcased at AATS Mitral Valve Conclave Dec 11–12, 2025
Negative
- None.
News Market Reaction
On the day this news was published, IART gained 1.23%, reflecting a mild positive market reaction. This price movement added approximately $12M to the company's valuation, bringing the market cap to $960M at that time.
Data tracked by StockTitan Argus on the day of publication.
PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, is pleased to announce 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 December 11 and 12, 2025.
About Integra LifeSciences
Integra LifeSciences (Nasdaq: IART) is a global medical technology leader dedicated to restoring lives. We are advancing transformational care through impactful innovation in neurosurgery and tissue reconstruction, specialized fields that demand exceptional expertise and precision. Our portfolio of highly differentiated, gold-standard technologies is trusted by healthcare professionals to deliver transformative care. For the latest news and information about Integra and its products, please visit www.integralife.com.
Investor Relations:
Chris Ward
(609) 772-7736
chris.ward@integralife.com
Media Contact:
Laurene Isip
(609) 208-8121
laurene.isip@integralife.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2795c2cd-fb23-4998-8dd9-8147f524564c
FAQ
What did Integra (IART) announce on November 11, 2025 regarding CUSA Clarity?
Which cardiac procedures are covered by the CUSA Clarity 510(k) clearance for IART?
When and where will Integra (IART) spotlight CUSA Clarity for cardiac use?
Does the CUSA Clarity clearance change its existing surgical indications for IART?
What type of FDA submission secured the cardiac indication for IART's CUSA Clarity?
