Ethicon Endo-Surgery Receives 510(K) Clearance For New HARMONIC ACE®+ Shears with Adaptive Tissue Technology
Next generation product empowers surgeons to handle multiple surgical jobs with even greater precision, building on the strong innovative foundation of a uniquely designed HARMONIC® energy portfolio
CINCINNATI, OH (August 8, 2012) –Ethicon Endo-Surgery, Inc. (EES) today announces U.S. FDA 510(k) clearance of the HARMONIC ACE®+ Shears with Adaptive Tissue Technology (HARMONIC ACE® + Shears), the next generation product in the best-in-class HARMONIC® portfolio of ultrasonic surgical devices that can handle multiple surgical jobs – including dissection, sealing, transection, and otomy creation. HARMONIC ACE®+ Shears set a new standard for precision with these innovative features:
- Adaptive Tissue Technology - Responds intelligently to varying tissue conditions by regulating energy delivery and providing surgeons with enhanced audible feedback. This enables the HARMONIC ACE®+ Shears to exhibit 23% less thermal spread while delivering 21% shorter transection times, compared with the current HARMONIC ACE®.[1,2]
- Refined blade design -Tapered, coated blade designed for multi-functionality with precise grasping and dissection.
HARMONIC ACE®+ Shears are designed for use in numerous specialties and procedures including General, Bariatric, Colorectal, GYN, and Urology, enhancing surgeons’ ability to handle multiple jobs with superior precision.
“I like how the Adaptive Tissue Technology senses and responds with improved energy delivery and the generator tone changes,” said Paul Kemmeter, MD, Bariatric Surgeon, Grand Health Partners (Grand Rapids, MI). “It makes me feel very comfortable knowing that the optimal amount of energy will be delivered consistently each time.”
Used in more than 14 million surgical procedures around the world, the HARMONIC® portfolio has grown to offer the most comprehensive options of innovative, multi-functional, precise devices. Since its first surgical use in 1992, HARMONIC® ultrasonic technology helped launch the laparoscopic evolution, and enabled surgeons to develop innovative techniques that help define the standards of care.
“With the introduction of Adaptive Tissue Technology,the HARMONIC ACE®+ Shears elevate the precision of the HARMONIC® portfolio,” said Tom O’Brien, EES Vice President, Global Strategic Marketing. “Based on surgeon feedback, EES will continue to advance the performance and precision of HARMONIC® devices through better energy management and refined design. We will also ensure our products make clinical and economic sense to all of our customers.”
About Ethicon Endo-Surgery Advanced Energy Ethicon Endo-Surgery 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.
About Ethicon Endo-Surgery Ethicon Endo-Surgery, Inc. is the world’s leader in providing advanced surgical solutions for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at www.ees.com.
 Reduction in thermal spread exhibited in porcine histology (2.2mm vs. 1.7mm, p<0.001).
 Shorter transection time as measured in porcine labs (5.7s vs. 4.5s, p<0.001).
 Dr. Kemmeter is a paid consultant for Ethicon Endo-Surgery
 As of January 20, 2012. Data on file at Ethicon Endo-Surgery, Inc.