510(k) For Ethicon Endo’s New HARMONIC ACE®+ Shears With Adaptive Tissue Technology

In short

Ethicon Endo-Surgery, Inc. has announced U.S. FDA 510(k) clearance of its HARMONIC ACE®+ Shears with Adaptive Tissue Technology. Never one to hide its light under a bushel, the company says this represents the next generation in its “best-in-class” HARMONIC® portfolio of ultrasonic surgical devices that can handle multiple surgical jobs – including dissection, sealing, transection, and otomy creation.

Background

Ethicon Endo-Surgery was a pioneer in laparoscopic surgery devices and remains a leader in advanced energy solutions, offering the broadest portfolio of ultrasonic energy devices using HARMONIC® technology and advanced bipolar energy devices using ENSEAL® technology.

The company claims its newly FDA cleared HARMONIC ACE®+ Shears set a new standard for precision, featuring Adaptive Tissue Technology which 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]. Furthermore the system’s tapered, coated blades are  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 precision.

Clinician comments

“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.” [3]

Company comments

“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.”

References

[1] Reduction in thermal spread exhibited in porcine histology (2.2mm vs. 1.7mm, p&0.001).

[2] Shorter transection time as measured in porcine labs (5.7s vs. 4.5s, p&0.001).

[3] Dr. Kemmeter is a consultant for Ethicon Endo-Surgery

Source: Ethicon Endosurgery, Business Wire