STOP POST PROCEDURE OOZING & BLEEDINGStandardize, simplify and minimize post procedure care and maintenance from interventional radiology procedures with StatSeal®, a topical hemostatic dressing that quickly forms an occlusive seal to stop the flow of blood and exudates. Comprised of a hydrophilic polymer and potassium ferrate, StatSeal works independently of the clotting cascade to seal the site, while accelerating hemostasis and reducing hold times by 50% or more, regardless of anticoagulation levels.1-3

THE STATSEAL SOLUTIONStatSeal is available in both powder and disc (compressed powder) form to suit a wide variety of clinical applications. For all interventional radiology procedures, StatSeal is more than a hemostat; it works with any protein-rich body fluid to seal the site, while stopping oozing and bleeding. Integrating StatSeal into IR lab protocols has been found to result in significant clinical, economical and operational efficiencies.1-3

Instantly creates an occlusive seal

• Significantly accelerates hemostasis1-4

• Seal strengthens with pressure and over time• Reduces hold times by 50% or more1-4

• Creates a barrier to microbial penetration5

Minimizes dressing disruptions6-7

• Reduces site exposure6-7

• Eliminates need for 24 to 48 hour post-insertion dressing changes6-7

• Keeps sites dry and intact, for up to 7 days6-7

Improves outcomes

• Reduces clinician time and material cost6-7

• Facilitates same-day discharge; seal goes home with patient4

• Minimizes site complications and helps reduce risk of infection1-3

StatSeal®

Seal the Site. STAT.™

InterventionalRadiology

Safety and efficacy of a rapid deflation algorithm for patent hemostasis following radial intervention (PROTEA)4

Method: Evaluation of a rapid deflation protocol using StatSeal in conjunction with a compression device in 323 patients undergoing transradial procedures, with a 7 Fr sheath size or less and no more than 5000 IU of heparin.Results:• 25 minute hemostasis time• 2 hour “same day” discharge• No increase in complications (0.92% Grade 1 hematoma)Conclusion: Rapid hemostasis after transradial intervention can be safely achieved within 25 minutes using StatSeal in conjunction with a compression device.

Above: StatSeal Advanced Plus Disc for femoral sheath removal

Below: StatSeal Advanced RAD Disc for radial sheath removal

STATSEAL® APPLICATIONS StatSeal® seals the site while stopping oozing and bleeding from:• Indwelling catheter placements and removals• Arterial and venous sheath removals• Biopsy and drainage procedures• Pain managment procedures and treatments• Dialysis access and interventions• Oncological procedures• Any procedure resulting in external bleeding and oozing

HOW DOES STATSEAL WORK?As an adjunct to manual pressure, StatSeal’s mechanism of action is two-step and occurs simultaneously to instantly form a low pH, “nothing in/nothing out” seal or physical barrier:

• The hydrophilic polymer rapidly dehydrates the blood and absorbs exudate, stacking up blood solids beneath to form a seal.

• The potassium ferrate agglomerates the solids and proteins together, adhering the seal to the wound to stop bleeding and oozing.

Beneath the seal, the pH is neutral and the blood solids and proteins continue to stack naturally. Above the seal, the hydrophilic polymer exchanges protons for cations, resulting in desiccation properties and a pH of ~ 2, which creates a barrier to microbial penetration.5,7

StatSeal® is Manufactured by Biolife, LLC8163 25th Court East • Sarasota, FL 34243 • USA • +1 941.360.1300 • customer.care@biolife.com • www.statseal.comMKT-FORM-037.0

References: [1] Condry H, Jara C. Use of StatSeal Advanced Disc to Decrease Time to Hemostasis in Transradial Cardiac Procedures/ A Quality Improvement Project. International Journal of Nursing Science. 2016; 6(4):103-107. [2] Rollefson W, Nash G, Cilingiroglu M, et al. Utilization of Potassium Ferrate Hemostatic Disc to Accelerate Time to Hemostasis in Transradial Cardiac Procedures. Poster presented at SCAI, Orlando, FL. 2016; May. [3] Wang DS, Chu LF, Olson SE, et al. Comparative evaluation of noninvasive compression adjuncts for hemostasis in percutaneous arterial, venous, and arteriovenous dialysis access procedures. J Vasc Interv Radiol. 2008 Jan;19(1):72-9. [4] De Korompay N, Klass D, Chung J, et al. Safety and efficacy of a rapid deflation algorithm for patent hemostasis following radial intervention (PROTEA). In: Proceedings from the Society of Interventional Radiology; March 4-9, 2017; Washington DC. Abstract 301. [5] Biolife, LLC, 510(k) K080210, Section 18.3. [6] Wilder KA, Wall B, Haggard D, Epperson T. CLABSI Reduction Strategy: A Systematic Central Line Quality Improvement Initiative Integrating Line-Rounding Principles and a Team Approach. Adv Neonatal Care. 2016 Jun;16(3):170-7. [7] Blough L, Hinson K, Hen J. The science of a seal for PICC line management: bio seal CVC powder. J VAS Access. 2010;15(2):66-73.

Below: Actual scanning electron microscopy image of

StatSeal surrounding a catheter

StatSeal®

Above: StatSeal Powder minimizes dialysis catheter

dressing disruptions

InterventionalRadiology

H 2O

and

Catio

ns

Desiccation, pH 2

Microbes

StatSeal®

The SealBelow the seal: pH = neutral

Above the seal: pH = 2

Catheter

Left: StatSeal Advanced Discs for fistuloplasty sheath removal