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Product approval

Ethicon’s Harmonic ACE+ 7 shears gain FDA approval

Technology designed to improve surgeon confidence in vessel sealing

Ethicon Endo-Surgery has announced that its Harmonic ACE+ 7 shears with advanced hemostasis has received 510(k) clearance from the FDA. The company claims that the Harmonic ACE+ 7 shears with advanced hemostasis is the first ultrasonic surgical device indicated to seal vessels up to and including 7mm, while also delivering on the Harmonic promise of precision and multi-functionality.

The Harmonic ACE+ 7 represents the latest evolution in the Harmonic legacy of innovation. The device leverages the proprietary Adaptive Tissue Technology, which enables the system to actively sense and adapt to changing tissue conditions and intelligently deliver energy resulting in improved performance with superior precision.

“I use Harmonic because it offers me the ability to perform precise dissection that you simply don’t get with an advanced bipolar energy device. However, the advanced bipolar energy devices have always been able to seal larger vessels,” said Dr Bartley Pickron, Colon and Rectal Surgeon, Colorectal Surgical Associates, Houston, Texas. “The addition of the 7mm vessel sealing capability to the Harmonic ACE+ 7makes it an optimal tool for laparoscopic colon surgery. Previously, I would have to use a Harmonic ACE for tissue dissection and then another device, such as stapler, clips, or endoloops, for control of the larger vascular pedicle. The development of the Harmonic ACE+ 7 has the potential for improved operative efficiency by eliminating instrument exchanges during a procedure. Furthermore, the avoidance of using multiple instruments should result in a cost savings for the overall procedure.”

Harmonic ACE+ 7 shears with advanced hemostasis designed for use in numerous procedures and specialties including general, colorectal, bariatric, gynecology, thoracic and urology, enhancing surgeons’ ability to handle multiple jobs with superior precision. The company believes the new Harmonic ACE+7 is best suited for cases which require dissection, mobilization and large vessel sealing.

“We continue to set the standard for performance in both ultrasonic and advanced bipolar energy,” says Tom O’Brien, Ethicon Vice President, Energy Global Strategic Marketing. “The recent introduction of our Enseal G2 Articulating (advanced bipolar) tissue sealer and now the 510(k) clearance of the new Harmonic ACE+7 both demonstrate our commitment to developing meaningful innovations that can help improve outcomes in critical procedures, while giving surgeons the best choices to meet the needs of their unique patients and procedures.”

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