SURGICEL® Powder Absorbable Hemostat

SURGICEL Powder is the next generation of the world's #1 trusted brand of topical absorbable hemostats.1,2 Designed to control continuous oozing bleeding on broad surfaces.3

SURGICEL® Powder Absorbable Hemostat

Features & Benefits

Absorbable Hemostat with different mechanism of action vs Arista Powder

Gets to the Source of the Bleed

SURGICEL® Powder penetrates the blood to stop bleeding at the source, achieving hemostasis in a wet field.4,5 Blood saturates the material, providing a surface for platelet adhesion and aggregation, and initiating clot formation.4,5

Hemostatic powder for durable clot with irrigation

Creates a Strong, Durable Clot6

SURGICEL Powder is made of 100% SURGICEL® material in powder form to efficiently and effectively stop continuous oozing bleeding on broad surfaces1,5,6 SURGICEL Powder sustains hemostasis even when irrigated.6 It is fully absorbable in 7-14 days.7,8

Hemostatic powder is not fully expressed with Arista Powder

Consistent Expression of Hemostatic Powder

SURGICEL Powder delivers consistent expression of powder for about 15 pumps, regardless of the device’s orientation. ARISTA™ AH expresses most of its product in just 2 pumps when vertical and is empty after 5 pumps. When horizontal, it is unable to express about the last 1/3 of its powder, which can lead to waste.9

Hemostatic Powder bactericidal against MRSA MRSE VRE PRSP E Coli

Proven Bactericidal10

SURGICEL Powder is 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).10†

Product Specifications

Product Code

Product Code

Description

 
3013SP 3013SP Oxidized Regenerated Cellulose (ORC) powder 

Product Code

Product Code

Description

 
3123SPEA 3123SPEA 2-in-1 Endoscopic Applicator 

Resources

Resources

SURGICEL® Powder Overview Video
SURGICEL® Powder Overview Video
05:31
SURGICEL® Powder MOA & Competition Video
SURGICEL® Powder MOA & Competition Video
04:21
Surgicel Powder Highlights Video
Surgicel Powder Highlights Video
02:51

Supporting Documentation

Product Support

SURGICEL® Powder Optimized Device Performance Guide

SURGICEL® Powder Brochure

SURGICEL® Powder vs Arista AH

 

SURGICEL® Powder in Hysterectomy Brochure

SURGICEL® Powder in Myomectomy Brochure

 

SURGICEL® Powder in Liver Resection Brochure

 

Clinical Support

SURGICEL® Compendium of Scientific Literature

References

*Based on preclinical testing in a swine acute liver biopsy model.

†The clinical benefit of these bactericidal claims has not been studied or demonstrated.

1. SURGICEL® Technical Report. 2018. Ethicon, Inc. 

2. Ethicon Global Share Reporting Process. March 2019. Ethicon, Inc.

3. MacDonald M. Study comparing performance of SURGICEL® Powder—Absorbable Hemostatic Powder to marketed competitive powdered topical hemostats in a swine acute liver abrasion model. Final Report, PSE Accession No. 16-0006, Project No. 16438. March 8, 2016. Ethicon, Inc.

4. Wang A. Surface energy/tension analysis among ORC aggregate, ORC fine fiber, and Arista – Project PIXIE. Ethicon, Inc.

5. MacDonald M. Pivotal study comparing performance of SURGICEL® Powder—Absorbable Hemostatic Powder to SURGICEL® Original Absorbable Hemostat in a swine acute liver abrasion model. Final Report, PSE Accession No. 15-0061, Project No. 16438. September 2, 2015. Ethicon, Inc.

6. MacDonald M. Pivotal study comparing performance of SURGICEL® Powder—Absorbable Hemostatic Powder to ARISTA™ Absorbable Hemostatic Particles and PerClot® Polysaccharide Hemostatic System in a swine acute live biopsy model. Study 15-0120, Project 16438. September 2, 2015. Ethicon, Inc.  

7. Buehler E. Evaluation of tissue acceptability and absorbability in a rat subcutaneous implant mode. April 26, 1993. Ethicon, Inc.  

8. Morris T. Evaluation of hemostasis in swine. Project No. 95-8799-21. 1995. Ethicon, Inc.  

9. Expression testing—ADAPTIV Document 100293850-1. Ethicon, Inc.

10. SURGICEL® Absorbable Hemostat. Full Prescribing Information, Ethicon, Inc.


SURGICEL® Powder Absorbable Hemostat Essential Product Information

INDICATIONS

SURGICEL® Powder (oxidized regenerated cellulose) s used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL® Powder can also be applied in laparoscopic or other endoscopic procedures when used with the SURGICEL™ Endoscopic Applicator. The SURGICEL™ Endoscopic
Applicator is intended for use in delivering SURGICEL® Powder absorbable hemostat to bleeding surgical sites through a 5 mm or larger trocar.

CONTRAINDICATIONS

• Do not inject or place SURGICEL® Powder into an open blood vessel. Do not use to treat bleeding from large defects in arteries or veins.

• SURGICEL® Powder should not be used to control hemorrhage from large arteries or veins.

• The SURGICEL® Powder and the SURGICEL™ Endoscopic Applicator devices were not designed for intraluminal procedures.

• When SURGICEL® Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure.

• SURGICEL® Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical chance of cyst formation.

WARNINGS

• SURGICEL® Powder is not intended for use on dry (non-bleeding) surfaces or for prevention of bleeding.

• Closing with SURGICEL® Powder in a contaminated wound without drainage may lead to complications and should be avoided.

• SURGICEL® Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances. 

• SURGICEL® Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in powder scattering and device migration that may increase the risk of adhesion formation. In preclinical in vivo animal studies it was demonstrated that SURGICEL® Powder does not increase the incidence of remote adhesions in laparoscopic procedures.

• Although SURGICEL® Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections.

• To prevent clogging with the SURGICEL™ Endoscopic Applicator Tip, do not touch the tip to wet surface. Be careful to avoid damaging tissue with the rigid tip.

• Do not attempt to trim the applicator tip. Replace the tip if it becomes clogged.

PRECAUTIONS

• SURGICEL® Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems.

• Use only as much SURGICEL® Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction.

• Use minimal amount of SURGICEL® Powder required to achieve hemostasis, and remove excess powder in the area of drains to prevent clogging.  In urological procedures, minimal amounts of SURGICEL® Powder should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

• Since absorption of SURGICEL® Powder could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.

• If SURGICEL® Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline solution after bleeding has stopped.

• Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling hemorrhage after tonsillectomy and controlling epistaxis).

• The applicator tip provided on the SURGICEL® Powder device is not intended for laparoscopic or other endoscopic use. If laparoscopic or other endoscopic use is desired, remove the existing applicator tip from the SURGICEL® Powder device, and replace with the SURGICEL™ Endoscopic Applicator tip (supplied separately). In laparoscopic or other endoscopic procedures, SURGICEL® Powder should only be applied using the SURGICEL™ Endoscopic Applicator. Consult the SURGICEL™ Endoscopic Applicator Instructions for Use (IFU) for proper assembly and directions for use with the SURGICEL® Powder device.

• The SURGICEL Endoscopic Applicator is supplied with a flexible inner tip inside a rigid cannula. The rigid cannula cannot be used independently.

• The SURGICEL Endoscopic Applicator should only be used by persons having adequate training and familiarity with endoscopic techniques.  Consult medical literature relative to techniques, complications, and hazards prior to performance of any endoscopic procedure.
 
• To prevent inadvertent device spillage, or unintended contact with tissue, organs, or blood, maintain visualization of the SURGICEL™ Endoscopic Applicator tip at all times.

• Do not compress or excessively bend the flexible inner tip of the SURGICEL Endoscopic Applicator which could obstruct the application of the powder.  It is possible that the powder accumulated in the applicator could disperse beyond the target bleeding site upon compression of the bellows, which may require additional irrigation and aspiration.

ADVERSE EVENTS 

• Paralysis and nerve damage have been reported when other SURGICEL® products were used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm. 

• Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when other SURGICEL® products were placed in the anterior cranial fossa (see WARNINGS and PRECAUTIONS).

• Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats.

• Burning has been reported when other SURGICEL® products were applied after nasal polyp removal. Headache, burning, stinging, and sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL® product was applied on surface wounds (varicose ulcerations, dermabrasions, and donor sites) have also been reported.

• For more information and technical questions, call 1-800-795-0012.  For complete information including indications, contraindications, warnings, precautions, adverse reactions, and directions for use, consult the product package insert.

071582-190227