StatSeal ® Don’t Just Cover It…Seal It. StatSeal StatSeal DISC ® For Venous Access Sites ® StatSeal For Wounds and Procedures For Large-Bore Catheters and Arterial Access Sites Seal the Site. STAT. TM With the Family of Products That Stop Bleeding and Help Protect Wounds and Procedural Sites ® What is StatSeal? StatSeal medical devices, in powder or disc form, are made of a hydrophilic polymer and potassium ferrate. When placed on an external bleeding wound or procedural site, in combination with manual pressure, StatSeal forms a seal that stops bleeding and helps protect the site from contamination. Seal formation is independent of the clotting cascade. How Do StatSeal Products Work? StatSeal quickly forms a seal to stop the flow of blood and exudates, and protect the site from contamination. The mechanism of action is a simultaneous two-step action: 1. The polymer rapidly dehydrates the blood, stacking up the solid components. 2. The potassium ferrate agglomerates the blood solids creating a seal or physical barrier. Beneath the seal, the blood clots naturally. In-Vitro studies* show that on the distal side of the seal, pH is low (~2) while on the proximal side of the seal, pH is neutral. StatSeal (unactivated powder) “The Seal” Illustration of seal formation Scanning Electron Microscopy (SEM) photo of seal StatSeal works for patients of any age. * Study report on file at Biolife LLC StatSeal Patented Technology That Stops External Bleeding From Wounds and Procedures What Is It? StatSeal Powder quickly forms a seal to stop external bleeding and oozing from wounds and procedures. The powder’s ingredients are a hydrophilic polymer and potassium ferrate. StatSeal Powder is effective for: • • • • • • • • Vascular access site bleeding and oozing Skin tears Lacerations Avulsions Biopsies and excisions Wound debridement Other non-suturable wounds Bleeding from sutures The Benefits of StatSeal Powder • Seal forms instantly upon contact with blood or exudate, strengthening with pressure and time • Does not rely on the body’s clotting cascade to create a seal • Works for patients of any age Improves Outcomes • Increases patient comfort and satisfaction • Hypo-allergenic, not biologically derived • Fewer dressing changes and occurrences of rebleeds SPFI03 Controls Bleeding and Oozing Efficient and Cost-effective • Fast hemostasis and fewer dressing changes saves valuable nursing time • Less expensive than other hemostats StatSeal ® Instructions for Use - Skin Tears, Avulsions and Other Non-Suturable wounds Application includes 1 bottle, 1 Powder Containment Device (PCD) and 1 product description label. Use of the PCD is optional. The PCD and foam insert can help contain powder when applied to vertical surfaces. 1. Clean wound and ensure blood or exudate is present. 2. Tap bottom of bottle to pour powder directly onto blood or bloody exudate. Cover bleeding area completely. Occasionally upon application, a temporary warming or stinging sensation is felt. 3. Apply pressure for 30 seconds to 2 minutes to form the protective seal. not recommended). If bleeding continues, repeat application. (Holding pressure with gauze is 4. Dress the wound with non-adherent dressing. The protective seal is safe to leave in place until it falls off naturally. Instructions for Use – Vascular Access Sites Before applying powder, secure catheter near access site. Catheter movement after powder is applied can disrupt newly-formed seal. 1. Place PCD around site, pour powder into PCD. Place foam center in PCD to cover powder. 2. Hold continuous pressure for 2 minutes to form seal; increase hold times as clinically necessary. 3. If bleeding continues, reapply more powder and hold manual pressure until bleeding stops. 4. Cover with transparent dressing following normal protocol; press and form transparent dressing around powder to help contain powder around access site. Site should remain dry and intact until next scheduled dressing change. You may feel a slight warming from the powder as it forms the seal. To remove StatSeal: If StatSeal Powder must be removed, as determined by a healthcare professional, brush away loose powder then wet the seal with sterile water/saline until seal starts loosening from the wound. Gently scrape off loosened seal with gloved finger. Repeat as needed. 1-800-722-7559 www.statseal.com StatSeal advanced Powder and Disc ® What Is It? Patented Technology to Seal Access Sites Following Sheath and Catheter Removal StatSeal® ADVANCED is a manual pressure adjunct that controls external bleeding from large-bore venous catheters, arterial access procedures, and other diagnostic or interventional procedures. Available in both powder and disc (compressed powder) form, the ingredients are a hydrophilic polymer and potassium ferrate. Disc/Powder + Pressure = Seal As an adjunct to manual pressure, StatSeal® ADVANCED forms a physical seal through agglomeration of blood solids and proteins along with simultaneous rapid dehydration of the blood. The Benefits of StatSeal® ADVANCED Reduces hold times • Does not rely on the body’s clotting cascade • Seal forms instantly and strengthens with pressure and time • The seal stays with the patient Improves outcomes • Increases patient comfort and satisfaction • Allows for re-access of the site • Hypo-allergenic, non-irritant Improves facility throughput • Efficient and Cost-effective • Less expensive than pads, patches and closure devices • Versatile – useful in the control of any external bleeding • Saves valuable staff time StatSeal® ADVANCED achieved hemostasis in less than two minutes for venous access and four minutes for arterial procedures based on results from a randomized controlled clinical study. StatSeal® effectively reduced time to hemostasis with minimal associated complications (hematoma, rebleeds). StatSeal® is superior to the control (D-Stat®) in reducing time to hemostasis.* *Michael D. Kuo, MD et al. Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arteriovenous Dialysis Access Procedures; Journal of Vascular and Interventional Radiology. Vol. 19, Number 1, January 2008. SPFI02r1 StatSeal ® Instructions for Use - StatSeal® ADVANCED Powder Application includes 1 bottle, 1 Powder Containment Device (PCD) and 1 product description label. StatSeal ® HPS01r3 Leave scab in place as directed TOPICAL HEMOSTATIC POWDER 1. 2. 3. 4. 5. 6. 1. Clean and dry the area around the site. Withdraw sheath leaving at least 3 to 4 centimeters (2-3 cms for fistula/grafts) under the skin. Remove PCD from package, peel paper backing and center (PCD) around sheath. 2. Pour powder into PCD* - lift sheath gently to ensure powder gets under sheath, then create a pile of powder around the sheath and completely fill the PCD. 3. Place PCD center (foam insert) over powder. Pull sheath slowly while applying pressure over the arteriotomy and the insertion site. 4. StatSeal® Advanced is a manual pressure adjunct. For initial uses, start at current manual pressure hold times then gradually adjust down toward 5 to 10 minutes of continuous pressure. Extend hold times as clinically necessary. 5. Release pressure slowly; Roll fingers off PCD**. 6. Place transparent dressing per protocol; Apply product description label on top of dressing to identify powder. Follow your normal ambulation protocol. * Fill PCD completely; don’t overfill; the bottle contains excess powder in case of a rebleed. ** If bleeding continues, reapply more powder (if necessary) with manual compression until bleeding has stopped. You may feel a slight warming from the powder as it forms the seal. To remove Statseal® Advanced: If Statseal® Advanced Powder must be removed, as determined by a healthcare professional, brush away loose powder then wet the seal with sterile water/saline until seal starts loosening from the wound. Gently scrape off loosened seal with gloved finger, cotton swab or tongue depressor. Repeat as needed. Instructions For Use: StatSeal® ADVANCED Disc Application includes 1 StatSeal® Advanced Disc. 1. Open sterile packaging and remove disc. 2. Place disc over the sheath at access site, align disc slit with sheath. Pull sheath slowly while applying pressure directly over the arteriotomy and puncture site. 3. Hold continuous semi-occlusive pressure over disc and arteriotomy site for >=5 minutes (Extend hold times as necessary for larger sheaths or anticoagulated patients). 4. Release pressure slowly to check for hemostasis. Apply additional pressure as necessary. 5. Place transparent dressing per protocol. Apply product description label. 6. Leave disc in place for 24 hours or as directed by clinician. 1-800-722-7559 www.statseal.com StatSeal Disc ® Seal the Site. STAT. The Challenge: How to Protect an Access Site • “Soiled, wet or loose dressings must be changed” since they provide an optimum environment for bacterial growth according to CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011. • Soiled gauze or CHG-impregnated sponges have been clinically shown to result in frequent dressing changes.1 • Dressing changes require valuable nursing time, added material cost and expose the site. Access site with soiled CHG sponge • Dressing disruption is a major risk factor for catheter-related infections.* The Solution: StatSeal® Disc The patented technology of StatSeal ® (BioSeal) Powder, now in an easy-to-use disc! StatSeal® Disc is a topical disc, made of compressed powder (hydrophilic polymer and potassium ferrate) that forms a seal over an access site to keep it dry and intact. StatSeal® Disc is available in various sizes to fit securely around different sizes of catheters (1.9-14 Fr). Benefits of StatSeal® Disc: Creates a seal that prevents bleeding and oozing • Seal forms instantly, strengthening with manual pressure and time • Does not rely on the body’s clotting cascade • Works with any protein-filled fluid Helps minimize dressing changes • Seals sites from insertion to 7 days, virtually eliminating 24 or 48-hour dressing changes • Helps minimize unplanned dressing changes due to bleeding and oozing • Helps follow CDC guidelines by keeping sites dry and intact Helps improve outcomes for patients and staff • Less exposure of site - Improves delivery of atraumatic care • Saves nursing time and costs “The StatSeal® disc is a game changer! For PICC and central line insertions, the disc keeps sites dry and intact. It is truly the future of hemostasis and vascular access site care.” Louis Guzzi, MD – Critical Care Medicine, Florida Hospital 1Timsit, et al, JAMA, March 25, 2009, “Chlorhexidine-Impregnated Sponges and Less Frequent Dressing Changes for Prevention of Catheter-Related Infections in Critically Ill Adults”. *”Timsit JF, Bouadma L, Ruckly S, et al, Crit Care Med. 2012;40:1707-1714 ”Dressing Disruption Is a Major Risk Factor for Catheter-Related Infection,” SPFI01r4 SDTE01r2 StatSeal ® The Difference is the Seal DISC How does StatSeal® Disc Work? StatSeal® quickly forms a seal to stop the flow of blood and exudates. The mechanism of action is a simultaneous two-step action: 1. The polymer rapidly dehydrates the blood, stacking up the solid blood components. 2. The potassium ferrate agglomerates the blood solids creating a physical barrier. Beneath the seal, the blood clots naturally. Instructions For Use: Application includes 1 StatSeal® Disc. StatSeal® Disc is intended for use under the care of a health care professional for the temporary external control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters. 1. Prepare the skin around insertion site according to facility protocol. 2. Open sterile packaging and remove disc. 3. Place the disc by sliding it down the catheter until it touches skin at the catheter site. The brown side should be towards the patient’s skin and the slit perpendicular to the catheter. The edges of the slit should approximate one another to the extent possible. The foam side is facing up. Tip: Don’t stretch the disc apart too much upon application. 4. Apply a continuous hold on top of the foam for at least 2 minutes to form the seal; increase the hold time as clinically necessary. 5. Secure the catheter per protocol. 6. Cover with transparent dressing following facility protocol. 7. Remove disc with next dressing change and resume regular dressing protocol. Site should remain dry and intact until next scheduled dressing change. Close up of underside of foam showing compressed powder With StatSeal® Disc, it’s ONE and DONE! 1-800-722-7559 www.statseal.com StatSeal in Clinical and Laboratory Studies ACHIEVES RAPID HEMOSTASIS, STOPS OOZING In a peer-reviewed clinical trial published in the Journal of Vascular and Interventional Radiology (January 2008) comparing the efficacy of two compression adjuncts in 176 percutaneous vascular access procedures, StatSeal was twice as fast in achieving hemostasis as the control with no differences in infections or adverse events. Results: StatSeal reduced mean time to hemostasis to under 4 minutes for arterial procedures.* Mean Time to Hemostasis (min.) Control (D-Stat) StatSeal Procedure Type Arterial - Therapeutic 3.56 9.99 Arteriovenous Dialysis Access 3.41 7.26 *Hold times may vary due to anticoagulation levels, sheath sizes or clinical techniques. Michael D. Kuo, MD, et al, Comparative Evaluation of Noninvasive Compression Adjuncts for Hemostasis in Percutaneous Arterial, Venous, and Arteriovenous Dialysis Access Procedures; Journal of Vascular and Interventional Radiology. Vol. 19, Number 1, January 2008. PROVIDES BETTER PATIENT OUTCOMES A peer-reviewed clinical trial published in the Journal of the Association for Vascular Access** showed that when used for all PICC line insertions (418) and occasional bleeding during dressing changes at Florida Hospital, StatSeal: • Showed a 40% decrease in Catheter-Related Bloodstream Infections (CRBSIs) during and post-trial • Eliminated the 48-hour dressing change; initial dressing change performed at 7 days • Achieved fast hemostasis, even for patients with clotting difficulties (≤ 2 min. in 96% of applications) • Resulted in no reported complications. ** Lauren Blough, RN, BS, CRNI, Kathy Hinson, BS, RN, MN, MPH, MBA, John Hen, PhD, “The Science of a “Seal” for PICC Line Management: BIOSEAL CVC Powder As An Alternative Hemostatic Agent That Keeps Sites Dry And Intact,” Journal of the Association for Vascular Access, Summer 2010, 15:2, 66-73. In a study of Mohs Micrographic Surgery, StatSeal showed greater efficacy and more rapid onset of action in second intention healing compared with the control compressed foam sponge (at week 12). StatSeal reduced erythema and produced fewer incidents of scarring. Leon Kircik, MD and James Q. DelRosso, DO. Journal of Drugs in Dermatology (JDD), February 2010, Vol. 9, Issue 2: 137-140, StatSeal Powder applied to a Mohs site SPFI04 StatSeal® Product Ordering Information StatSeal ® DISC StatSeal® Disc - Extra Small to Large size: For temporary external control of bleeding from percutaneous catheters StatSeal® ADVANCED Disc - For temporary external control of bleeding from sheath and catheter removals Underside of foam showing compressed powder disc Extra Small ~1.9-4 FR Small Medium ~6-9 FR ~10-14 FR Carton DT613 DS614 DM615 DL616 DA618 Case DT623 DS624 DM625 DL626 DA628 Carton 6 6 6 6 6 Case 24 24 24 24 24 Size ~4-6 FR Large Advanced Item Number: Number of Applications: StatSeal ® StatSeal® Powder Stops external bleeding from wounds and procedures Manufacturer Item Number Description Number of Applications LP606 Carton 6 LP636 Case 24 StatSeal ® StatSeal® ADVANCED Powder Seals arterial access sites SPFI05r3 Manufacturer Item Number Description Number of Applications LP607 Carton 6 LP637 Case 24 StatSeal ® Seal the Site. STAT. TM 8163 25th Court East, Sarasota, FL. 34243 1-800-722-7559 • www.statseal.com SSPF01
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