You are about to leave jnjmedtech.com. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies.
SURGICEL Powder Absorbable Haemostat
SURGICEL Powder Absorbable Haemostat
Built to stop continuous, broad-surface oozing* fast1-4**,¥
IMAGES
Features & Benefits
SURGICEL Powder Absorbable Haemostat penetrates through the blood to stop bleeding at the source, effectively achieving haemostasis in a wet field5,6≠
The structure of SURGICEL Powder Absorbable Haemostat allows it to penetrate the surface of the blood to get to the source of bleeding.13,14
SURGICEL Powder Absorbable Haemostat provides a surface for platelet adhesion and aggregation, working with the patient's endogenous clotting factors to initiate clot formation10
Control of Bleeding
SURGICEL Powder provides efficient control^ of continuous oozing* bleeding on broad surfaces.7-8,15,*,† After haemostasis has been achieved, irrigation of excess powder can be performed and the bleeding site will not re-bleed.9,†† Fully absorbable in 7 to 14 days.10,≥
Proven Bactericidal
Proven bactericidal in vitro against a broad range of gram-positive and gram-negative organisms, including various antibiotic-resistant bacteria (MRSA, VRE, PRSP and MRSE)11,12
SURGICEL Powder
Named a “Gold Winner" in the “Drug-Delivery Devices and Combination Products” by the Medical Design Excellence Awards.***
Supporting Documentation
Resources
References
1.Ethicon, SURGICEL Powder versus SURGICEL Original. Final Report, PSE Accession No. 15-0061, Project No. 16438, September 2015, Data on file (080594-170919)
2.Ethicon, SURGICEL Powder versus Competitive Powdered Hemostats. Final Report, PSE Accession No. 16-0006, Project No. 16438, March 2016, Data on file (080594-170919)
3.SURGICEL Powder Absorbable Hemostat, Instructions for Use. Ethicon, Inc. (080594-170919)
4.Ethicon, K-5678 Surgicel Endoscopic Applicator Summative Usability Design Validation Surgeon and Nurse Study, December 2016, Data on File (080594-170919)
5.Ethicon, 25_2-59164 Surface energy/tension analysis among ORC Aggregate, ORC Fine Fiber, and Arista – Project PIXIE, March 2017, Data on File (116968-190619)
6.US Patent Compacted Hemostatic Cellulosic Aggregates - Application 20170128618, May 11 2017, Available from https://patents.justia.com/patent/20170128618 (116968-190619)
7.Ethicon, SURGICEL Powder versus Competitive Powdered Hemostats. Final Report, PSE Accession No. 16-0006, Project No. 16438, March 2016, Data on file (079002-170822)
8.Ethicon, Market Research on unmet need, Project Pixie Global Positioning Report, Dec 2014, Data on file (079002-170822)
9.Ethicon, Inc. SURGICEL Powder versus ARISTA™ AH. Final Report, PSE Accession No. 15-0120, Project No. 16438, September 2015, Data on File (079007-170822)
10.Hutchinson et al. Hemostatic efficacy and tissue reaction of oxidized regenerated cellulose hemostats. Cellulose;2012;9828-8 (117062-190620, 109987-190321 )
11.SURGICEL Powder Absorbable Hemostat, Instructions for Use. Ethicon, Inc. (078999-170822)
12.Data on File - 100408840-2 ORC Powder Bactericidal efficacy (078999-170822)
13.Ethicon, Surface energy/tension analysis among ORC Aggregate, ORC Fine Fiber, and Arista – Project PIXIE, March 2017, Data on file (079001-170822
14.Ethicon, US Patent Compacted Hemostatic Cellulosic Aggregates - Application 20170128618, May 11 2017, Data on file (079001-170822)
15.MacDonald et al, An in vivo comparison of the efficacy of hemostatic powders, using two porcine bleeding models, Medical Devices: Evidence and Research. 2017:10 273–279
* Continuous oozing defined as bleeding that will not stop with compression / simple packing
** TTH study of surgicel powder show average time to haemostasis of 30 seconds
*** SURGICEL Powder is neither a drug delivery device or a combination product
^ Trial based on biopsy and abrasion on more than 70 animal livers which had higher effective hemostasis rate (p<0.002) and faster TTH (p<0.001)
¥ is ready to use out of the package with no preparation required
≠ As demonstrated in vitro
≤ Based on a preclinical animal study
≥ As shown in animal models
† vs Arista
†† Based on a pre‐clinical animal study. Re‐bleeding did not occur in 90% of evaluated test sites
166442-210204
© Johnson & Johnson Medical Limited 2021. All Rights Reserved.