Ethicon Gets 510(k) Clearance for New Shears With Adaptive Tissue Technology

The U.S. Food and Drug Administration has given Ethicon Endo-Surgery Inc. 510(k) clearance for its Harmonic Focus+ Shears with adaptive tissue technology, a next-generation ultrasonic surgical device that responds “intelligently” to varying tissue conditions by regulating energy delivery. The product represents the fifth 510(k) clearance for Ethicon Energy’s portfolio this year.

The new Harmonic Focus+ leverages the company’s adaptive tissue technology first introduced in Harmonic Ace+ earlier this year. This technology enables the system to actively sense and adapt to changing tissue conditions and intelligently deliver energy resulting in improved performance with superior precision. In addition, the new slimmer profile is designed to increase speed and visibility, as well as improved dissection.

“I currently use Harmonic Focus as it provides a number of novel utilities in my surgical practice beyond traditional utility in thyroid surgery. The instrument allows for hemostatic resection with minimal blood loss. There is also a marked minimal thermal spread which can impact on interpretation of surgical margins,” said Dennis Kraus, M.D., Otolaryngology, North Shore-LIJ Cancer Institute, New York, N.Y. “With the enhanced precision that comes with the Focus+ Shears, it has the potential to eliminate the need for instrument exchanges and further improve my operative efficiency.”

Harmonic Focus+ is designed for various procedures and specialties including ear, nose and throat (ENT), and general.

“As we move toward the future, our adaptive tissue technology will serve as a platform for developing a portfolio of Harmonic devices that offer even greater functionality and benefits, providing surgeons increased choice and the flexibility to meet their diverse set of clinical needs for their patients and procedures,” said Tom O’Brien, Ethicon’s vice president of Energy Global Strategic Marketing.

Harmonic ultrasonic devices, according to the company, are designed for precise dissection, sealing and transection. One device enables surgeons to perform multiple jobs without instrument exchanges. Devices in the line are used for open and laparoscopic procedures that require precision throughout various surgical specialties including general, colorectal, bariatric, vascular, gynecology, ENT, urology, thoracic, and plastic and reconstructive.

Ethicon and Ethicon Endo-Surgery are divisions of Johnson & Johnson.