Ethicon obtains FDA 510(k) clearance for new shears with adaptive tissue technology

13 December 2013 (Last Updated December 13th, 2013 06:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ethicon Endo-Surgery's new Harmonic Focus+ shears with adaptive tissue technology, a next-generation ultrasonic surgical device that actively responds to varying tissue conditions by regulating energy delivery.

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The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ethicon Endo-Surgery's new Harmonic Focus+ shears with adaptive tissue technology, a next-generation ultrasonic surgical device that actively responds 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 proprietary adaptive tissue technology that was originally introduced in Harmonic Ace+ earlier in 2013.

In addition, the new slimmer profile is designed to increase speed and visibility, as well as improved dissection.

North Shore-LIJ Cancer Institute New York Otolaryngology Dr Dennis Kraus said: "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.

"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."

"The instrument allows for hemostatic resection with minimal blood loss."

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

Ethicon energy global strategic marketing vice-president Tom O'Brien said: "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."

According to the company, Harmonic ultrasonic devices are designed for precise dissection, sealing and transaction. Single 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, gynaecology, ENT, urology, thoracic, and plastic and reconstructive treatment


Image: Harmonic Focus+ Shears with Adaptive Tissue Technology. Photo: courtesy of Business Wire/ Ethicon Endo-Surgery.