* De acordo com dados de mercado internos e externos.
¥ Comparando com a HARMONIC™ ACE+7, demonstrado em estudos de engenharia e pré-clínicos.
≠ Num teste de bancada comparando os tempos de selagem da HARMONIC ACE+7 e HARMONIC HD1000i. A HARMONIC HD1000i transecionou vasos mais rápido do que a HARMONIC ACE+7 (tempo médio de transeção dos vasos de 9.186 segundos vs. 15.291 segundos).
± Fiabilidade da selagem a 240 mmHg de 98.2% vs. 98.4% para a HARMONIC™ ACE™+7 com o botão MIN. Velocidade com base no tempo médio para transecionar 150mm de jejuno suíno (p>0.001).
≤ Num estudo em modelo suíno, comparando os tempos de selagem da HARMONIC™ ACE™+7 e da HARMONIC™HD1000i. A HARMONIC™ HD1000i transecionou os vasos mais rápido do que a HARMONIC™ ACE™+7 (tempo médio de transeção dos vasos de 9.186 segundos vs 15.291 segundos).
µ Com base num estudo pré-clínico em vasos suínos e num estudo de bancada em artérias carótidas suínas de 5-7mm que demonstrou que a pressão à rutura média da HARMONIC™ HD1000i foi, pelo menos, 36% superior à dos produtos similares.
** Com base numa avaliação pré-clínica.
≥ Comparando com a HARMONIC™ ACE+7.
∞ Comparando com as gerações anteriores dos dispositivos HARMONIC™.
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)
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