FDA Clears Ethicon-Endo’s New Harmonic Focus®+ Shears With Adaptive Tissue Technology

Ethicon’s Endo-Surgery Division will now be able to market the company’s new Harmonic Focus® + Shears following FDA 510(k) clearance. The “+” indicates that the device features so-called Adaptive Tissue Technology, which moderates energy delivery dependent on the tissue encountered.

Background

Harmonic Focus®+ is described in a company press release as a next generation ultrasonic surgical device that now incorporates Ethicon’s proprietary Adaptive Tissue Technology, bringing the HARMONIC® promise of precision to open procedures.

Ethicon says the new Harmonic Focus®+ leverages its Adaptive Tissue Technology that was originally 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 claimed superior precision. In addition, the new slimmer profile of the new device is designed to increase speed and visibility, as well as improved dissection.

Harmonic Focus®+ is designed for use in numerous procedures and specialties including ENT and General, and promises enhanced ability to handle multiple jobs with superior precision.

Physician comments

“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 Dr. Dennis Kraus, MD, Otolaryngology, North Shore-LIJ Cancer Institute, New York, NY. “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.”

Company comments

“Harmonic Focus®+ is the latest example of our commitment to developing meaningful innovations that can help improve outcomes in critical procedures,” says Tom O’Brien, Ethicon Vice President, Energy Global Strategic Marketing.

“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.”

Source: Ethicon Endo-Surgery, Inc.,

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