Healthcare Industry News:  Ethicon Endo-Surgery 

Devices FDA

 News Release - October 29, 2013

Ethicon Receives 510(k) Clearance of Ear, Nose and Throat (ENT) Indication for ENSEAL(R) Tissue Sealers

New indication expands surgeon choice to both advanced bipolar (ENSEAL®) and the leading ultrasonic technology (HARMONIC®) in ENT procedures

CINCINNATI--(Healthcare Sales & Marketing Network)--In an effort to expand surgeons’ choices to both advanced bipolar and ultrasonic energy technology in open and laparoscopic procedures, Ethicon Endo-Surgery, Inc. (Ethicon) today announces the 510(k) clearance from the U.S. Food and Drug Administration for an expanded indication of Ear, Nose and Throat (ENT) procedures for the ENSEAL® tissue sealers. The new indication applies to both the first and second generation devices including: ENSEAL® Trio, ENSEAL® Round Tip, ENSEAL® G2 Curved Tissue Sealer, and ENSEAL® G2 Straight Tissue Sealers.

Surgeons will now be able to choose their ENT surgical device from either the ENSEAL® portfolio known for its superior sealing capability or from the HARMONIC® portfolio known for its precision and multi-functionality. Combined, these portfolios represent the broadest offering of both advanced bipolar and ultrasonic energy by one company in the ENT space. The HARMONIC® devices already indicated for ENT include the HARMONIC SYNERGY® Blades and the HARMONIC FOCUS® Curved Shears – 100% of the top ENT programs in the U.S. use HARMONIC FOCUS® device1.

“Every patient and every surgery is unique,” says Dr. Joe Amaral, Ethicon Vice President Worldwide Energy Surgical Science. “With that in mind we continue to strive to offer surgeons the best in both advanced bipolar and ultrasonic so they can choose the device best suited to improve outcomes for their patients.”

About Our Energy Portfolio

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.

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.

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 worldwide2. 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 surgery; Gynecology, ENT, Urology, Thoracic, and Plastic and Reconstructive. Click here to learn more.

About Our Company

Ethicon represents the products and services of Ethicon, Inc. and Ethicon Endo-Surgery, Inc., two companies with long histories of medical innovation, which provide globally a broad range of surgical technologies and products (including energy devices, sutures, staplers, clip appliers, trocars and meshes) used 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.

1 Top-ranked hospitals for ear, nose and throat. U.S. News & World Report. Accessed January 1, 2013. Internal sales data. February 2012 to January 2013.

2 Internal sales data as of June 10, 2013.

Source: Ethicon Endo-Surgery

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