* Benchtop testing on 1-7mm porcine splenic, thyrocervical and carotid arteries (mean burst pressure of 1400 mmHg). (C2241)
** STRATAFIX™ Symmetric PDS™ Plus Devices only
1.Ethicon Inc, PRC075988A, Burst Pressure - new algorithm vs old algorithm – FINAL, Dec 2016, Data on File.
2. Ethicon Inc, PRC075987A, Burst Pressure Protocol - New Algorithm vs Old Algorithm, Nov 2016, Data on File.
3. Ethicon Inc, PRC075988A, Burst Pressure-New Algorithm vs Old Algorithm -FINAL, Dec 2016, Data on File.
4. Ethicon Inc, PRC075987A, Burst Pressure Protocol - New Algorithm vs Old Algorithm, Nov 2016, Data on File.
5. Ethicon Inc, DR000142, 40 mm Curved Cutter Stapler Design Verification, Dec 2012, Data on File. (C1330)
Full claim: Controlled Tissue Compression and Adjustable Height Staple technology is designed to enable surgeons to create a secure anastomosis with effective perfusion to promote healing. (C2001).
6. Ethicon Inc, SCN045048, Summary of Design Intent for ETHICON Intraluminal Stapler (ILS) to Support Claims, Mar 2016, Data on File.
7. Ethicon Inc, Instructions for Use ETHICON ENDO-SURGERY Endoscopic Curved Intraluminal Stapler (ILS).
Full claim: STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices provide excellent holding strength and can be used in high-tension areas, such as fascia.
8. Ethicon Inc, EMEA SFX Claim 060117-160915, May 2017, Data on File.