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SURGICEL Powder Absorbable Haemostat
Built to stop continuous, broad-surface oozing* fast1-4**,¥
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
Product Resources
Resources
150167-200817 UK Surgicel Powder Video
Supporting Documentation
Resources
SURGICEL Powder Optimal Device Performance (ODP) Quick Guide
SURGICEL Powder Customer Brochure
SURGICEL Powder Coverage Surface Area Comparison
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
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