Ethicon HARMONIC HD 1000i Shears Receives U.S. FDA 510(k) Clearance
CINCINNATI, July 5, 2016 /PRNewswire-USNewswire/ -- In an effort to transform energy solutions to make measurable clinical and cost-of-care improvements for healthcare providers and patients globally, Ethicon,[i] a leading global provider of medical devices, today announces that HARMONIC® HD 1000i has received 510(k) clearance from the U.S. FDA. The HARMONIC HD 1000i is a next generation ultrasonic surgical device designed to address unique challenges in complex open and laparoscopic procedures.
The HARMONIC HD 1000i offers a seamless combination of unmatched precision, unparalleled strength, and optimal efficiency for easier dissection, faster transection and more secure sealing. Its unique blade design delivers more secure seals, even in the most challenging hemostasis conditions, and its increased sealing speed, multi-functionality, and simplified steps allow for optimal efficiency.
The exclusive shape of Harmonic HD1000i mimics a mechanical dissector, reducing the need to use a separate dedicated dissecting instrument. Unlike previous generations, the HARMONIC® HD 1000i hand piece is integrated into the device, driving clinical performance, and eliminating the need to order, manage, or clean a separate item.
HARMONIC HD 1000i is designed for use in numerous procedures and specialties including Hepato-pancreato-biliary, Thoracic, Colorectal, and Gynecologic Oncology, enhancing surgeons' ability to handle multiple jobs with expert precision and superior performance.
"HARMONIC HD 1000i is the latest example of our commitment to developing meaningful innovations that can help improve outcomes in critical, complex procedures," says Grace Chung, Ethicon Vice President, Energy Global Strategic Marketing. "As we move toward the future, HARMONIC HD 1000i will serve as a platform for developing a portfolio of HARMONIC® devices focused on solving unmet surgical needs through our in-depth knowledge of tissue and energy sciences to enable surgeons to reach more patients and restore more lives."
Ethicon is the proven leader in advanced energy with more than 17 million procedures performed worldwide1, and the most complete advanced energy portfolio for open and laparoscopic procedures across multiple surgical specialties. Through innovation at every touchpoint from ideation to the surgeon's hand, Ethicon offers the broadest range of ultrasonic energy devices using HARMONIC® technology and advanced bipolar energy devices employing our distinct ENSEAL® technology. Click here to learn more.
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.
Ethicon Worldwide Communications Contact:
Office: 513 337-8180
[i] Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. Ethicon Endo-Surgery, LLC. is the legal manufacturer of HARMONIC HD1000i.
1 Internal sales data as of June 10, 2013
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