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Integra Gets FDA OK for Ultrasonic Surgical Aspirator for Cardiac Surgery

The new indications cover debridement of unwanted tissue in cardiac surgeries, including valve replacement and repair.

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By: Sam Brusco

Associate Editor

The CUSA Clarity ultrasonic surgical aspirator. Photo: Integra

Integra LifeSciences has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for use of its CUSA Clarity ultrasonic surgical aspirator system for cardiac surgeries. The new indications cover debridement of unwanted tissue in cardiac surgeries, including valve replacement and repair.

CUSA Clarity is also indicated for surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is needed, like neurosurgery, plastic and reconstructive surgery, orthopedic surgery, thoracic surgery, laparoscopic surgery, gynecological surgery, and liver resection and transplant surgery.

The company plans to highlight the ultrasonic surgical aspirator at next month’s American Association for Thoracic Surgeon Mitral Valve Conclave.

“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 VP 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.”

In September, Integra hired Dr. Raymond Turner as its new corporate VP and chief medical officer (CMO). Dr. Turner held leadership roles at Siemens Healthineers, including his most recent position as CMO of Siemens Endovascular Robotics. Before that, he was a medical director for Cerenovus, a Johnson & Johnson MedTech company.

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