• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Special Reports
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Resources
    • About MassDevice
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
    • In-Depth Coverage
    • Latest News
  • Attend DeviceTalks
    • Events
      • DeviceTalks Minnesota – May 4
      • DeviceTalks Boston – May 27–28
      • DeviceTalks West
      • DeviceTalks Tuesdays
    • DeviceTalks Podcast Network
      • DeviceTalks Weekly
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Advertise
  • Subscribe
Home » Integra wins FDA nod for ultrasonic surgical aspiratory system for cardiac surgeries

Integra wins FDA nod for ultrasonic surgical aspiratory system for cardiac surgeries

November 12, 2025 By Sean Whooley

Integra LifeSciences Clarity CUSA System
The CUSA Clarity aspiration console (left) and handpieces (right). [Images courtesy of Integra LifeSciences]
Integra LifeSciences (Nasdaq: IART) announced that it received FDA 510(k) clearance for its CUSA aspirator system for cardiac surgeries.

CUSA (Clarity Ultrasonic Surgical Aspirator) now has clearance for specific cardiac indications. Indications now encompass the debridement of unwanted tissue in cardiac surgeries. These include valve replacement and repair.

Princeton, New Jersey-based Integra said that, in addition to cardiac surgery, the FDA granted CUSA an indication for use in surgical procedures. These procedures include when fragmentation, emulsification and aspiration of soft and hard (bone) tissue is desirable. This extends CUSA’s uses to a range of surgeries beyond cardiac. Those include 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, EVP 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.”

CUSA Clarity’s console combines four components into one integrated system, according to the Integra LifeSciences website. The company designed it to provide the power and precision needed for quick, safe debulking of fibrous tissue. It pairs with multiple handpiece offerings.

The Power handpiece (23 kHz) offers use in more challenging neurosurgical procedures, such as tough tissue and bone removal. Integra’s Precision handpiece (36 kHz) offers more safety and control, according to the company.

Filed Under: 510(k), Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Gynecological, Neurological, Regulatory/Compliance, Replacement Heart Valves, Structural Heart, Surgical, Transplants Tagged With: FDA, Integra LifeSciences

More recent news

  • Citi downgrades Boston Scientific as cyberattack recovery compounds competitive pressure
  • Autonomix taps former Medtronic FDA counsel head for board of directors
  • Medtronic strengthens robotic surgery position with Cornerstone deal, analysts say
  • Science Corp. names president as it looks to roll out vision-restoring implant
  • Mindray looks to fill hospital ventilator gap left by Philips’ exit

About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

Cart

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >
MDO ad
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2026 · Arrowfly LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Arrowfly.

Privacy Policy