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FDA Clearance for HARMONIC FOCUS+ Shears

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Adaptive Tissue Technology empowers surgeons to handle multiple surgical jobs with greater precision.

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Manufacturing Group December 16, 2013

In an effort to drive greater efficiency in surgery, Ethicon Endo-Surgery, Inc. (Ethicon) officials announces that HARMONIC FOCUS+ Shears with Adaptive Tissue Technology (HARMONIC FOCUS+) has received 510(k) clearance from the U.S. FDA. The HARMONIC FOCUS+ is a next generation ultrasonic surgical device that now brings Adaptive Tissue Technology to open procedures while delivering on the HARMONIC promise of precision. This is the fifth 510(k) clearance for the Ethicon Energy portfolio this year. 

The new HARMONIC FOCUS+ leverages the proprietary 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 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 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.” 

HARMONIC FOCUS+ is designed for use in numerous procedures and specialties including ENT and General, enhancing surgeons’ ability to handle multiple jobs with superior precision. 

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.” 

Ethicon is a leader in advanced energy solutions and offers the broadest portfolio of ultrasonic energy devices using HARMONIC technology and advanced bipolar energy devices using ENSEAL technology. Click here to learn more. 

HARMONIC ultrasonic devices combine precision and multifunctionality: Uniquely designed for precise dissection, sealing and transection, one device enables surgeons to perform multiple jobs without instrument exchanges. HARMONIC technology is the proven leader in advanced energy with more than 16 million procedures worldwide1. Devices in the HARMONIC portfolio are used for open and laparoscopic procedures that require precision. The portfolio can be used across a range of surgical specialties: General, Colorectal, Bariatric, Vascular, Gynecology, ENT, Urology, Thoracic, and Plastic and Reconstructive. Click here to learn more. 

ENSEAL Tissue Sealers consistently cut and seal vessels up to and including 7mm through high uniform compression. Devices in the ENSEAL portfolio are intended for use during both open and laparoscopic surgical procedures where division of vessels, lymphatics and tissue bundles is performed. These surgical specialties include: General, Colorectal, Bariatric, Gynecology, Thoracic, Plastic and Reconstructive, Urology, and ENT.

Source: Ethicon Inc.

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