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HARMONIC 1100 Shears
HARMONIC 1100 Shears
Ultrasonic leader proven to minimize the impact on tissue1-10*
Fast transection, precise dissection and Improved temperature control11-15¥
IMAGES
Features & Benefits
Fast transection13,16-18≠
The Energy button is designed to provide the reliable sealing of the MIN button on ACE™+7 with the cutting speed of the MAX button on ACE™+712,13,19-21±
HARMONIC 1100 shears transected faster than HARMONIC ACE+7 when transecting vessels 5-7mm in diameter using Advanced Hemostasis mode13,16-18≠
Precise Dissection
Unique blade design delivered secure seals22,23µ
Curved, tapered tip has enabled more precise dissection than HARMONIC ACE+713,24,25**≥
Improved temperature control26∞
HARMONIC 1100 Shears has a next generation Adaptive Tissue Technology algorithm that actively controls blade heat to lower the maximum blade temperature of the device26∞
HARMONIC 1100 Shears maintains blade temperature when prolonged activation is required26
References
*As per designed and internal market share data
¥Compared to HARMONIC™ ACE+7 Shears as demonstrated in engineering and pre-clinical studies
≠In a bench top study comparing sealing times of HARMONIC ACE+7 and HARMONIC HD1000i. HARMONIC HD1000i Shears transected vessels faster than HARMONIC ACE+7 (mean vessel transection time of 9.186 seconds vs 15.291 seconds)
±Seal reliability at 240 mm Hg of 98.2% vs. 98.4% for HARMONIC™ ACE™+7 MIN button. Speed based on average time to transect 150mm of porcine jejunum (p>0.001)
≤ln a porcine study comparing sealing times of HARMONIC™ ACE™+7 and HARMONIC™HD1000i. HARMONIC™ HD1000i Shears transected vessels faster than HARMONIC™ ACE™+7 (mean vessel transection time of 9.186 seconds vs 15.291 seconds)
µBased on a pre-clinical study of porcine blood vessels and a benchtop study with 5-7mm porcine carotid arteries that showed median burst pressure of HARMONIC™ HD1000i was at least 36% more than Ligasure™ Maryland, Ligasure™ Blunt Tip, and Sonicision™
**Based on a Pre Clinical evaluation
≥Compared to HARMONIC™ACE+7
∞Compared to previous generations of HARMONIC™ devices
1. Ethicon, 01022019, Energy Devices Volume of Publications February 2019 - Literature Search Results, Feb 2019, Data on File (171107-210319)
2. Ethicon, 01022019, AE Publications, Feb 2019, Data on File (171107-210319)
3. Ethicon, 01022019, AE Publications Summary, Feb 2019, Data on File (171107-210319
4. Ethicon, 01122020, U.S. Market & Share Insights Report, Dec 2020, Data on File (171107-210319)
5. As Per Instructions For Use (171107-210319)
6. Ethicon, PRC042296A, Triton (FCS17) Thermal Spread in Vessels, Feb 2010, Data on File (171107-210319)
7. Ethicon, SCN008558A Triton (FCS17) Test Procedure: Thermal Spread on Vessels Following In Vivo Transection, April 2009, Data on File (171107-210319)
8. Ethicon, SCN049171A, Several HARMONIC FOCUS Shears, 9 cm Length (FCS9) approved claims shall also apply to HARMONIC FOCUS + Adaptive Tissue Technology, 9 cm Length (HAR9F) based on similarity of design memo, Feb 2017, Data on File (171107-210319)
9. Ethicon, 28082019, GBI Info - Harmonic Undisputed Claim memo, Aug 2019, Data on File (171107-210319)
10. Ethicon, 500660262B, HARMONIC Adaptive Tissue Technology memo, March 2021, Data on File (171107-210319)
11. Ethicon, PRC74432B: Buccaneer Energy Button Vessel Claims, April 2016, Data on File (176074-210823)
12. Ethicon, PRC094080B, Scarlet DV- Vessel Transection Speed (and Burst Pressure), March 2020, Data on File (176074-210823, 117220-210514)
13. Ethicon, SCN075090A, Scarlet Witch Physical Equivalence memo, April 2020, Data on File (176074-210823, 117222-210705, 117220-210514, 173360-210409)
14. Ethicon, PRC095370A, Project Scarlet: Blade Temperature, May 2020, Data on File (176074-210823)
15. Ethicon, PSP004888A, HARMONIC™ HD 1000i Open Shears (HARHD20) and HARMONIC™ HD, 1000i Laparoscopic Shears (HARHD36): Design Verification Acute Study in the Pig, march 2016, Data on File (176074-210823)
16. Ethicon, PRC074125B, Buccaneer DV- Vessel Transection Speed, March 2016, Data on File (117222-210705)
17. Ethicon, PRC092654A, Buccaneer Harmonic Burst Pressure Investigation, Nov 2019, Data on File (117222-210705, 117220-210514)
18. Ethicon, PRC051292A, Vic - transection time evaluation with surgeons, June 2011, Data on File (117222-210705)
19. Ethicon, PRC074432A, Buccaneer Energy Button Vessel Claims, April 2016, Data on File (117220-210514)
20. Ethicon, PRC074127B, Buccaneer DV- Transection Speed (Marching & Tip Bite), March 2016, Data on File (117220-210514)
21. Ethicon, PRC094084B, Project Scarlet – Marching Transection Speed (Full & Tip), March 2020, Data on File (117220-210514)
22. Ethicon, PSB004423, Project Buccaneer HARMONIC™ HD 1000i Laparoscopic Shears (HARHD36): Design Verification Chronic (30 day) Survival Study in the Pig , March 2016, Data on File (118720-210705)
23. Ethicon, PRC074054A Buccaneer Thermal Spread And Burst Claims, Feb 2016, Data on File (118720-210705)
24. Ethicon, PSP004888A, Project Buccaneer HARMONIC™ HD 1000i Open Shears (HARHD20) and HARMONIC™ HD 1000i Laparoscopic Shears (HARHD36): Design Verification Acute Study in the Pig, March 2016, Data on File (173360-210409)
25. Welling AL et al, Superior dissecting capability of a new ultrasonic device improves efficiency and reduces adhesion formation, Glob Surg. 2017;3(1):1-5 (173360-210409)
26. Ethicon, PRC095370C, Project Scarlet: Blade Temperature, May 2020, Data on File (176071-210705, 173361-210409)
190058-210922
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Last updated February 22, 2019. The third-party trademarks used herein are trademarks of their respective owners. Data and usage fees may apply. See your carrier for more information.
*As of March 2017, per internal research conducted by Ethicon.
Please refer always to the Instructions for Use / Package Insert that come with the device for the most current and complete instructions.