Featuring the Latest Innovation from the SURGICEL® Family of Absorbable Hemostats

SURGICEL® Powder Absorbable Hemostat is 100% SURGICEL® material in powder form for broad surface coverage1-3

Featuring the Latest Innovation from the SURGICEL  Family of Absorbable Hemostats

A SURGICEL® absorbable hemostat for every bleeding situation need

Ethicon Surgicel Powder Hemostat an alternative to Arista Powder

SURGICEL® Powder Absorbable Hemostat is uniquely structured1

SURGICEL Powder penetrates blood in a wet field  to stop bleeding at its source.2,4

Ethicon Surgicel Snow Hemostat an alternative to Surgicel Original Hemostat

SURGICEL SNoW™ Absorbable Hemostat allows for ease of repositioning without sticking to instruments5

Smart design retains its shape for better handling, conformability, and easier insertion through trocars.1,5*
 

Ethicon Surgicel Fibrillar Hemostat an alternative to Surgicel Original Hemostat

SURGICEL® FIBRILLAR™ Absorbable Hemostat “melts” into bleeding tissue1

Lightweight layers can be pulled apart and manipulated for intentional, precise placement.1

Ethicon Surgicel Nu-Knit Hemostat an alternative to Surgicel Original Hemostat

SURGICEL NU-KNIT® Absorbable Hemostat for continuous heavy bleeding

The dense ORC material can be secured in heavy, continuous bleeding situations.1,6*

Product Specifications

Product Code

Product Code

Description

 
1951 1951 Loose knit of oxidized regenerated cellulose (ORC) 

Product Code

Product Code

Description

 
1952 1952 Loose knit of oxidized regenerated cellulose (ORC) 

Product Code

Product Code

Description

 
1953 1953 Loose knit of oxidized regenerated cellulose (ORC) 

Product Code

Product Code

Description

 
1955 1955 Loose knit of oxidized regenerated cellulose (ORC) 

Supporting Documentation

Clinical Evidence

SURGICEL Compendium of Scientific Literature

Product Support

Biosurgery Non-Clinical Portfolio Sales Aid

Biosurgery portfolio

References

*Compared to SURGICEL Original.
 
1. SURGICEL® Technical Report. 2018. Ethicon, Inc. 

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

3. Expression testing- ADAPTIV Document 100293850-1. September 2, 2015. Ethicon, Inc.

4. Wang A. Surface energy/tension analysis among ORC Aggregate, ORC Fine Fiber, and Arista – Project PIXIE.

5. Helms J. ETHICON™ biosurgery SNoW marketing claims report. July 12, 2010. Ethicon, Inc.

6. Zhang G. Competitive assessments of hemostatic products. September 30, 2009. Ethicon, Inc.

 

SURGICEL Essential Product Information

• INDICATIONS

SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is 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® ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL® NU-KNIT®, and SURGICEL® SNoW™ Absorbable Hemostats can be cut to size
for use in endoscopic procedures.

• PRECAUTIONS

Use only as much SURGICEL® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction.

In urological procedures, minimal amounts of SURGICEL® Absorbable Hemostat 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® Absorbable Hemostat 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® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped.

Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples: controlling hemorrhage after tonsillectomy and controlling epistaxis.)

Care should be taken not to apply SURGICEL® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse Reactions section of the complete product package insert).


• ADVERSE EVENTS

“Encapsulation” of fluid and foreign body reactions have been reported.

There have been reports of stenotic effect when SURGICEL® Absorbable Hemostat has been applied as a wrap during vascular surgery.

Paralysis and nerve damage have been reported when SURGICEL® Absorbable Hemostat was 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 SURGICEL® Absorbable Hemostat was placed in the anterior cranial fossa.

Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported.

For more information, please consult your doctor or for product quality and technical questions, call 1-800-795-0012. For complete product information including indications, contraindications, warnings, precautions, and adverse reactions, please reference the individual product package inserts.

063768-180827


SURGICEL® Powder Absorbable Hemostat Essential Product Information

INDICATIONS

SURGICEL® Powder (oxidized regenerated cellulose) is 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