SURGIFLO® Hemostatic Matrix Kit
As surgery time increases, so does the value of SURGIFLO® Hemostatic Matrix1
The use of a flowable gelatin with thrombin such as SURGIFLO® may reduce surgical blood loss, operating time and hospital length of stay. For an average 4 hour spinal surgery, using SURGIFLO® Hemostatic Matrix with thrombin was associated with cost reduction of $150 per surgery versus Floseal.1
Effective performance and utilization
In blind testing, surgeons prefer the consistency of SURGIFLO® over Floseal®‡
When compared to Floseal® in blind testing, the use of SURGIFLO® resulted in preferred product consistency that remains uniformly flowable for 8 hours, quicker and easier preparation, and lower cost.
Fast hemostasis with staying power
SURGIFLO® Hemostatic Matrix stays in place even during active bleeding3,4**
SURGIFLO® stops bleeding in less than 2 minutes when mixed with thrombin. Its lightweight design allows for optimal control and ease of use, and its applicator allows for precise placement to address bleeding in tight and difficult-to-access sites.
Ease of preparation and safety5,6
SURGIFLO® is faster to prepare versus Floseal and requires no measuring
SURGIFLO® has significantly shorter thrombin reconstitution time versus Floseal (57 seconds vs. 90 seconds), plus a vial adapter designed to eliminate needle sticks. OSHA¶ Guidelines recommend the use of needle-free medical devices to reduce sharp injuries in the surgical setting.7
SURGIFLO® Hemostatic Matrix Kit PI
2994 SURGIFLO IFU
* Each product was prepared following Instructions for Use.
† Based on in vitro viscosity testing of SURGIFLO® 8mL and Floseal Hemostatic Matrix 5mL.
‡ Testing conducted with 101 US surgeons using SURGIFLO® versus Floseal.
**In animal models.
¶ Occupational Safety and Health Administration
1. David G, Lim S, Gunnarsson C, Kocharian R, Roy S. Similar patient outcomes yet different hospital costs between flowable hemostatic agents. J Med Econ 2015; 1-11.
2. Measurements of viscosity and Thrombin activity of SURGIFLO 2993 as compared to FLOSEAL over time. April 7, 2013.
3. Pilot evaluation comparing the time-to-hemostasis and hemostatic efficacy of Surgiflo®, next generation Surgiflo®, and Floseal (all prepared with thrombin) in an acute punch biopsy porcine spleen model: Final report 11-071. June 7, 2011.
4.042007-151015 Clymer Surgiflo Clinical Paper.pdf
5. Design validation report
6. EVITHROM® Thrombin, Topical (Human) Full Prescribing Information, Ethicon, Inc.
7. Revision to OSHA’s Bloodborne Pathogens Standard: Technical Background and Summary. Washington, DC: United States Department of Labor. www.osha.gov/needlesticks/needlefact.html. Published April 2001. Accessed November 10, 2016.
Important Safety Information
DESCRIPTION: SURGIFLO® Hemostatic Matrix Kit Essential Product Information (Made from Absorbable Gelatin Sponge, USP) with Thrombin
SURGIFLO® with Thrombin (SURGIFLO® Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.
When used in appropriate amounts SURGIFLO® is absorbed completely within 4 to 6 weeks.
SURGIFLO®, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.
• Do not use SURGIFLO® in intravascular compartments because of the risk of embolization.
• Do not use SURGIFLO® in patients with known allergies to porcine gelatin.
• Do not use SURGIFLO® in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.
• SURGIFLO® should not be used in the presence of infection and should be used with caution in contaminated areas of the body• SURGIFLO® should not be used in instances of pumping arterial hemorrhage. SURGIFLO® will not act as a tampon or plug in a bleeding site.
• SURGIFLO® should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm because it may swell resulting in nerve damage.
•Excess SURGIFLO® should be removed once hemostasis has been achieved.
• The safety and effectiveness of SURGIFLO® for use in ophthalmic procedures has not been established.
• SURGIFLO® should not be used for controlling post-partum intrauterine bleeding or menorrhagia.
• The safety and effectiveness of SURGIFLO® has not been established in children and pregnant women.
• The blue flexible applicator tip should not be trimmed to avoid exposing internal guidewire.
• The white straight applicator tip should be trimmed away from the surgical area. Cut a square angle to avoid creating a sharp tip.
• Safe and effective use of SURGIFOAM® Sponge has been reported in a published neurologic retrospective study involving 1700 cases in Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.
• SURGIFLO® is supplied as a sterile product and cannot be resterilized. • SURGIFLO® should not be used for packing unless excess product that is not needed to maintain hemostasis is removed. SURGIFLO® may swell up to 20% upon contact with additional fluid.
• SURGIFLO® should not be used in conjunction with autologous blood salvage circuits.
• SURGIFLO® should not be used in conjunction with methylmethacrylate adhesives. • In urological procedures, SURGIFLO® should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.
A total of 142 patients received SURGIFOAM® Sponge during a clinical trial comparing SURGIFOAM® Sponge to another absorbable gelatin sponge. In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:
• Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial growth.
• Giant cell granulomas have been observed at implant sites when used in the brain.
• Compression of the brain and spinal cord resulting from the accumulation of sterile fluid have been observed.
• Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.
• The use of absorbable gelatin-based hemostatic agents during the repair of dural defects associated with laminectomy and craniotomy operations, has been associated with fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and paresis.
• The use of absorbable gelatin-based hemostatic agents has been associated with paralysis, due to device migration into foramina in the bone around the spinal cord, and blindness, due to device migration in the orbit of the eye, during lobectomy, laminectomy, and repair of a frontal skull fracture and lacerated lobe.
• Foreign body reactions, “encapsulation” of fluid, and hematoma have been observed at implant sites.
• Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin-based sponges were used in severed tendon repair.
• Toxic shock syndrome was reported in association with the use of absorbable gelatin-based hemostats in nasal surgery.
• Fever, failure of absorption, and hearing loss have been observed when absorbable hemostatic agents were used during tympanoplasty.
Important Safety Information
DESCRIPTION: EVITHROM® Thrombin, Topical (Human) for Topical Use Only Lyophilized Powder for Solution
EVITHROM® Thrombin, Topical (Human) for Topical Use Only
Lyophilized Powder for Solution
EVITHROM® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical.
EVITHROM® may be used in conjunction with an Absorbable Gelatin Sponge, USP.
Important Safety Information
- For topical use only.
- Do not inject.
- Apply EVITHROM® on the surface of bleeding tissue only.
- The amount of EVITHROM® required depends upon the area of tissue to be treated and the method of application. In clinical studies, volumes up to 10 ml were used in conjunction with Absorbable Gelatin Sponge.
- Do not use for the treatment of severe or brisk arterial bleeding.
- Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. Hypersensitivity reactions, including anaphylaxis, may occur.
- There is a potential risk of thrombosis if absorbed systemically.
- May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of viral transmission.
- The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM®) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count.
- None of the patients treated with EVITHROM developed antibodies to human thrombin or to human Factor V/Va. The clinical significance of these findings is unknown.
- For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.