Ethicon Receives 510(k) Clearance for New HARMONIC FOCUS®+ Shears with Adaptive Tissue Technology

Adaptive Tissue Technology empowers surgeons to handle multiple surgical jobs with greater precision, building on the strong, innovative foundation of the uniquely designed HARMONIC® Energy product line

CINCINNATI--()--In an effort to drive greater efficiency in surgery, Ethicon Endo-Surgery, Inc. (Ethicon) today 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.”

About Our Energy Business
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. Click here to learn more.

About Our Company
Ethicon, Inc. and Ethicon Endo-Surgery, Inc., two companies with long histories of medical innovation, do business under the Ethicon brand. Their surgical technologies and products (including sutures, staplers, energy devices, clip appliers, trocars and meshes) are used around the world to treat colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. Ethicon, Inc. and Ethicon Endo-Surgery, Inc. are part of the Johnson & Johnson Family of Companies. Learn more at www.ethicon.com, or follow us on Twitter @Ethicon.

Safe Harbor Statement
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Ethicon Endo-Surgery, Inc. or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Ethicon, Inc., Ethicon Endo-Surgery, Inc. or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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1

  Internal sales data as of June 10, 2013.
Dr. Kraus is a paid consultant for Ethicon
 

Contacts

Energy Worldwide Communications
Bridgett Golden, 513-375-9524
bgolden@its.jnj.com
or
Ann Leibson, 513-479-1210
aleibso@its.jnj.com
or
Follow us on Twitter @Ethicon

HARMONIC FOCUS+ Shears with Adaptive Tissue Technology (Photo: Business Wire)

HARMONIC FOCUS+ Shears with Adaptive Tissue Technology (Photo: Business Wire)

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Release Summary

HARMONIC FOCUS®+ Shears with Adaptive Tissue Technology has received 510(k) clearance from the U.S. FDA. This ultrasonic surgical device now brings Adaptive Tissue Technology to open procedures.

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Contacts

Energy Worldwide Communications
Bridgett Golden, 513-375-9524
bgolden@its.jnj.com
or
Ann Leibson, 513-479-1210
aleibso@its.jnj.com
or
Follow us on Twitter @Ethicon