Skip to main content

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

Written by Customer Service on . Posted in Public Companies.

CUSA Clarity

CUSA Clarity Ultrasonic Surgical Aspirator System
CUSA Clarity Ultrasonic Surgical Aspirator System

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

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.