*Control and consistency by higher abdominal wall retention force, lower insertion force, consistently low leak rate, and maintaining procedural flow relative to reducing the need to re‐wipe (reclean) the endoscope due to smudging. 

Higher abdominal wall retention force: In pre‐clinical testing: Average abdominal wall retention force, Ethicon B5LT/2B5LT (9.8lbs) vs Applied Medical Kii Fios First Entry Z‐Thread 5mm CTF03 (5.9lbs, p<0.001) and Ethicon B12LT/2B12LT (19.4lbs) vs Medtronic VersaStep™ Plus VS101012P (7.9lbs, p<0.001).

Lower insertion force: In pre‐clinical testing, average abdominal wall insertion force, Ethicon B12LT (19.9lbs) vs Applied Medical Kii Fios® First Entry Advanced Fixation CFF73 (24.4lbs, p<0.001) and Medtronic VersaOne™ Optical 12mm Trocar ONB12STF (23.0lbs p=0.001).

Consistently low leak rate: Compared 5 mm trocars to other leading trocars: Medtronic and Applied Kii, (Medtronic ONB5STF, Applied Kii CFR03/ CTR03), on a benchtop test measuring leak rate with a 4.7mm probe inserted. Ethicon B5LT leaked significantly less compared to leading competitors: Medtronic ONB5STF, and Applied Kii CFR03 and CTR03. Ethicon B5LT leak rate distribution was
significantly less than CTR03, although the medians were both zero. Ethicon B5LT leak rate standard deviation was compared to leading competitors, 82% less than Medtronic ONB5STF, 93% less than Applied Kii CFR03 and 88% less than Applied Kii CTR03.

Maintaining procedural flow due to less smudging: In bench top tests comparing mean number of insertions for 5mm trocars out of 10 insertions with a quality index score of 92 or higher for Ethicon 2B5LT (6.4) to Applied Medical CFR03/CTR03/CTF03 (0.5), Medtronic VS101005 (0.4), p<0.05. In bench top tests comparing mean number of insertions for 12mm trocars out of 15 insertions with a quality index score of 92 or higher for Ethicon 2B12LT (11.6) to Applied Medical CTF73/CFF73/CFR73/C0R47 (0.4), Medtronic VS101012P (1.6), p<0.05. Quality index score of 92 or higher indicates a less than 20% chance of having to re‐wipe the endoscope lens due to trocar induced smudging.

1. Ethicon, PSB004498 Pre‐Clinical insertion & retention testing report, June 2016, Data on file (200508‐220106 EMEA)

2. Ethicon, PSB004559, Insertion and Retention Report, September 2016, Data on file (200508‐220106 EMEA)

3. Ethicon, PRC096502B Competitor Trocar Leak Performance Benchmarking, Sep 2020, Data on file (200508‐220106 EMEA)

4. Ethicon, PRC056628B Hermes Competitive Quality Index Testing, Oct 2012, Data on file (200508‐220106 EMEA)

5. Ethicon PRC049012D Competitive Tests of Access System Quality Image, Oct 2012, Data on file (200508‐220106 EMEA)
 

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