Ethicon Endo-Surgery, a subsidiary of Johnson & Johnson, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for the HARMONIC ACE+ 7 Shears with Advanced Hemostasis (HARMONIC ACE +7).
HARMONIC ACE+ 7 is an ultrasonic surgical device designed to seal vessels up to and including 7mm, while maintaining the HARMONIC promise of precision and multi-functionality.
The new device incorporates Ethicon Endo-Surgery's adaptive tissue technology, which allows the system to actively sense and adapt to changing tissue conditions and intelligently deliver energy, resulting in improved performance with superior precision.
Ethicon Endo-Surgery has designed the HARMONIC ACE+ 7 for use in numerous procedures and specialties including general, colorectal, bariatric, gynecology, thoracic and urology.
Ethicon energy global strategic marketing vice president Tom O'Brien noted the company continues to set the standard for performance in both ultrasonic and advanced bipolar energy.
"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," O'Brien added.
The new device is best suited for cases that require dissection, mobilization and large vessel sealing.