HEMOBLAST Training Book1.pdf

HIGH -PERFORM ANC E HEMOSTASIS M ADE SIMPLE. THAT’S REAL STOPPING POW ER. A NEW SOLUTION FOR TODAY’S BLEEDING CHALLENGES This material is intended for Health Care Professionals in the US. THE POW ER TO BE VERSATILE NOW HIGH-PERFORMANCE HEMOSTASIS IS SIMPLER THAN EVER: PROVEN Th...

HIGH -PERFORM ANC E HEMOSTASIS M ADE SIMPLE. THAT’S REAL STOPPING POW ER. A NEW SOLUTION FOR TODAY’S BLEEDING CHALLENGES This material is intended for Health Care Professionals in the US. THE POW ER TO BE VERSATILE NOW HIGH-PERFORMANCE HEMOSTASIS IS SIMPLER THAN EVER: PROVEN The only hemostatic agent clinically proven effective on the validated SPOT GRADE™ scale for minimal, mild, and moderate bleeding.1-13 READY TO USE No reconstitution, mixing, or thawing.1 CONTAINS HUMAN-DERIVED THROMBIN1 In the physiologic coagulation cascade, thrombin converts fibrinogen into fibrin.14 VERSATILE Effective for focal (pooling/flowing) bleeding*1 Allows broad coverage to treat large area bleeding without the need for a power source or spray kit1 Effective on bony and soft tissue1 *as evaluated on the SPOT GRADE™ scale THE FORMULA FOR SUCCESS: 3 SYNERGISTIC COMPONENTS +1 SIMPLE BELLOWS APPLICATOR = HIGH-PERFORMANCE HEMOSTASIS FOR A COHESIVE AND STABLE CLOT MECHANICAL HEMOSTASIS PHYSIOLOGIC HEMOSTASIS The (porcine-derived) collagen in HEMOBLAST™ Bellows contains HEMOBLAST™ Bellows supports COLLAGEN THROMBIN (human-derived) thrombin.1 a controlled swell.1 Additionally, Thrombin converts fibrinogen in the coagulation cascade, collagen to fibrin, a basic element in is known to induce platelet a blood clot.14 aggregation and coagulation.14 CHONDROITIN The clot formed SULFATE by HEMOBLAST™ COHESION Bellows offers HEMOBLAST™ Bellows is the only visibility of the hemostat that contains (bovine- wound site after derived) chondroitin sulfate,1 application. included for the purpose of The hemostatic providing cohesion between the powder resorbs wound and surrounding tissue. within 4 weeks. SEM photo showing HEMOBLAST™ Bellows clot chondroitin sulfate in a porcine liver model HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures. Refer to the back for additional Important Risk Information. THE ONLY PRODUCT INDICATED AS AN ADJUNCT TO HEMOSTASIS FOR MINIMAL, MILD, AND MODERATE BLEEDING ON THE SPOT GRADE™ SCALE1-13 Biom’up developed the SPOT GRADE™ scale or the Surface Bleeding Severity Scale (SBSS) to quantitatively determine the amount of bleeding from a surgical wound and standardize bleeding definitions across surgical specialties and procedures. HEMOBLAST™ Bellows performed impressively in our FDA-approved pivotal trial, in controlling SPOT GRADE™ bleeding levels 1 through 3, covering oozing to flowing bleeding.1 HEMOBLAST™ BELLOWS Effective hemostasis on SPOT GRADE™ levels 1 through 3: minimal, mild, and moderate bleeding SPOT GRADE™ SCALE for approved indications.1 SPOT GRADE ™ 0 1 2 3 4 5 Maximum Expected ACS-ATLS* 1 1 1 2 3 4 Shock Risk Class Severe; not Extreme; Verbal Descriptor None Minimal Mild Moderate immediately immediately life-threatening life-threatening Visual Descriptor Dry Oozing Pooling Flowing Streaming Gushing Manual pressure, Manual pressure, Manual pressure, Manual pressure, Manual pressure, Expected cautery, adjuvant cautery, suture, cautery, suture, cautery, suture, cautery, suture, None Intervention(s) adjuvant adjuvant staples, staples, hemostat(s) hemostat(s) hemostat(s) tissue repair tissue repair Flow Rate (mL/min) Ranges for Target Bleeding Site16 1 (cm2) 0 [0;4.8] [4.8; 12.0] [12.0; 25.3] [25.3; 102.0] [102.0; +∞] 10 (cm2) 0 [0;9.1] [9.1; 20.0] [20.0;71.3] [71.3; 147.4] [147.4; +∞] 50 (cm )2 0 [0;13.5] [13.5; 28.0] [28.0;117.3] [117.3; 192.7] [192.7; +∞] EFFICACY THAT’S PROVEN1 The US pivotal study evaluating the safety and efficacy of HEMOBLAST™ POSTOPERATIVE BLEEDING DATA Bellows against absorbable gelatin sponge and thrombin involved 242 0% patients randomized across 16 sites and found HEMOBLAST™ Bellows SIGNS OR SYMPTOMS statistically superior at achieving hemostasis: OF POSTOPERATIVE 71.1% vs. 45.8% at 3 minutes (p=0.0001)1 BLEEDING1 0% 93.1% vs. 73.5% at 6 minutes (p=0.0001)1 No clinical signs or symptoms of postoperative bleeding with REOPERATIONS DUE HEMOBLAST™ Bellows within 24 hours1 TO BLEEDING 1 Lower rate of surgical rescue treatment (2.9% vs. 13.3%) (p=0.0129)1 *American College of Surgeons – Advanced Trauma Life Support. THE POW ER TO PERFORM APPLICATION THAT’S EASY1 1 Blot Excess Blood Blot excess blood from the target bleeding site with a laparotomy pad/gauze or suction. The wound surface should be as dry as possible just before application. 2 Apply HEMOBLAST™ Bellows Apply HEMOBLAST™ Bellows to the source of bleeding by compressing the bellows. Enough implant material should be applied to cover the entire source of bleeding. 3 Hold Soaked Laparotomy Pad/Gauze Immediately apply wound-appropriate pressure using a soaked laparotomy pad/gauze. Hold for approximately 3 minutes. Gently lift the laparotomy pad/gauze and inspect the area. 4 Once Hemostasis is Achieved, Irrigate Excess Once hemostasis is achieved, excess powder not incorporated in the hemostatic clot should be removed by gentle irrigation. Please refer to the Instructions for Use for full prescribing information.1 THE ONLY POWDER WITH THROMBIN1,2,4-6 HEMOBLAST™ Bellows contains thrombin for efficacy on minimal, mild, and moderate bleeding on the SPOT GRADE™ scale.1 Handles Oozing, Pooling, and Flowing Bleeding* 1 OTHER POWDER HEMOSTATS† MINIMAL, CAPILLARY, VENOUS, AND MILD AND MODERATE (POOLING AND SMALL ARTERIAL/ FLOWING BLEEDING) ARTERIOLAR BLEEDING READY WHEN YOU NEED IT1 Because it does not require advance preparation, HEMOBLAST™ Bellows optimizes hospital staff time and provides a possible solution to avoid waste from unused product.1 Stay Ready for Unexpected Bleeding FLOSEAL® TISSEEL® SURGIFLO® EVICEL® D-STAT® READY TO USE REQUIRES REQUIRES RECONSTITUTION THAWING OR RECONSTITUTION AND ASSEMBLY LESS COST & HASSLE1,7,8 Unlike fibrin sealants, HEMOBLAST™ Bellows is proven effective on moderate bleeding, including pooling and flowing bleeding,* while possibly eliminating the extra cost, hassle, and risk of air gas embolism of a spray set and external gas set-up.1,7,8 Covers Pooling and No Spray Sets or Known Flowing Bleeding* 1 Risk of Air Gas Embolism *as evaluated on the SPOT GRADE™ scale THE POW ER TO SIMPLIFY APPLICATION VERSATILITY1 Compared to flowable hemostats, only HEMOBLAST™ Bellows easily allows coverage of focal and large area bleeding and does not require reconstitution.1 Handles Focal and Applied Dry, No Large Area Bleeding1 Reconstitution Required 1 MORE COVERAGE, MORE SAVINGS1,12,13,17-19 With up to 50 cm2 coverage per unit, HEMOBLAST™ Bellows provides more coverage for less cost than fibrin sealant patches.1,12,13,17-19 COST PER AREA COVERED (CM2) PER UNIT1,12,13,17-19 HEMOBLAST™ $5.00 Covers More Bleeding Hemostatic Agents Bellows (50 cm2)§ Area for Less1,12,13,17-19 TACHOSIL® (45.6 cm2) $13.86 EVARREST® (51.61 cm2) $15.92 $0.00 $2.00 $4.00 $6.00 $8.00 $10.00 $12.00 $14.00 $16.00 $18.00 Price (USD) †Other Powder Hemostats, including ARISTA™ AH, GELFOAM® POWDER, SURGICEL® POWDER, SURGIFOAM® POWDER were not evaluated using the SPOT GRADE™ scale. Their efficacy under this grading is unknown. §For larger areas, more than 1 HEMOBLAST™ Bellows may be needed. With excellent versatility and coverage, HEMOBLAST™ Bellows is designed to simply and effectively meet your bleeding challenges.1  HIGH-PERFORMANCE HEMOSTASIS MADE SIMPLE. HEMOBLAST™ Bellows is supplied as a preloaded bellows that: Contains 1.65 g of powder, including a maximum of 1,500 units of thrombin Includes a 10 cm nozzle extension to assist with application where a slightly longer tip is desired to reach the target bleeding site in open procedures Is biocompatible and non-pyrogenic APPLICATION VERSATILITY1 The HEMOBLAST™ Bellows Laparoscopic Applicator is: Intended for delivering HEMOBLAST™ Bellows hemostatic powder to bleeding surgical sites Compatible with a 5 mm diameter or larger trocar Sold separately from HEMOBLAST™ Bellows* *Please see the HEMOBLAST™ Bellows and HEMOBLAST™ Bellows Laparoscopic Applicator Instructions for Use for complete information on the hemostatic agent. PART NUMBER DESCRIPTION MINIMUM ORDER QTY BQF02-US 1 EA. HEMOBL AST ™ BELLOWS AND 1 EA. 10 CM NOZZLE EXTENSION 1 CASE/12 EA. L AP01-US 1 EA. INDIVIDUALLY PACK AGED L APAROSCOPIC APPLICATOR 1 CASE/12 EA. REQUEST A CLINICAL EVALUATION ORDER HEMOBLAST™ OR DEMONSTRATION AT: BELLOWS AT: 1-877-GO-DILON (1-877-463-4566) 1-877-GO-DILON (1-877-463-4566) dilon.com/Hemoblast [email protected] 1. HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Dilon Technologies, Inc. 2. ARISTA AH Absorbable Hemostatic Particles Instructions for Use. CR Bard, Inc. 3. Avitene Microfibrillar Collagen Hemostat [instructions for use]. CR Bard, Inc. 4. Gelfoam Absorbable Gelatin Powder [instructions for use] Pharmacia and Upjohn Co. 5. Surgicel sales brochure. 074300-170608. Somerville NJ; Ethicon Inc. 6. Surgifoam Absorbable Gelatin Powder package insert. Somerville NJ; Ethicon Inc. 7. TISSEEL Fibrin Sealant [prescribing information]. Deerfield, IL: Baxter Healthcare. 8. Evicel Fibrin Sealant [prescribing information]. Somerville NJ; Ethicon Inc. 9. FLOSEAL Hemostatic Matrix [instructions for use]. Deerfield, IL: Baxter Healthcare. 10. SURGIFLO Hemostatic Matrix Kit [instructions for use]. Somerville, NJ; Ethicon Inc. 11. D-Stat Flowable Hemostat Instructions for Use. Vascular Solutions, Inc. 12. TachoSil Fibrin Sealant Patch [prescribing information]. Takeda AS. 13. Evarrest Fibrin Sealant Patch [prescribing information]. Somerville, NJ; Ethicon Inc. 14. Spotnitz, W. Hemostats, Sealants, and Adhesives: A Practical Guide for the Surgeon. Am Surg. 2012;78:1305-1321. 15. Dilon Technologies, Inc., internal data. Data derived from clinical use of 186 cases in Germany and France (PME report). 16. Spotnitz, WD; Zielske, D; Centis, V; et al. The SPOT GRADE: A New Method for Reproducibly Quantifying Surgical Wound Bleeding. Spine. 2018;43(11):E664-E671. 17. 2016 IMS Hemostat Revenue, Unit, and ASP Sales Data. 18. Dilon Technologies, Inc., company data. ET-2015-001-PC-019. 19. Dilon Technologies, Inc., company data. Caution: Federal law restricts this device to sale on or by the order of a physician. Important Risk Information for HEMOBLAST™ Bellows: Do not inject HEMOBLAST™ Bellows into a vessel or tissue. There is a risk of allergic-anaphylactoid reaction and/or thromboembolic events, which may be life-threatening. Do not apply HEMOBLAST™ Bellows in the absence of active blood flow, e.g., while the vessel is clamped or bypassed. Extensive intravascular clotting and even death may result. Do not administer to patients with known allergies or hypersensitivity to materials of porcine or bovine origin. Because HEMOBLAST™ Bellows is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. HEMOBLAST™ Bellows contains chondroitin sulfate from bovine origin which is associated with a remote risk for Transmissible Spongiform Encephalopathies (TSE), which has been minimized in accordance with regulatory guidelines by a manufacturing process with demonstrated TSE inactivation capacity. When applied to a bleeding site, HEMOBLAST™ Bellows swells up to 60% within about 5 minutes. Do not attempt to trim the applicator tip. HEMOBLAST™ Bellows should not be used at the site of a valve replacement or repair as valvular dysfunction could occur. HEMOBLAST™ Bellows should not be applied at the site of a synthetic graft or patch implant due to potential for decreased effectiveness. The product should not be in contact with circulating cerebrospinal fluid (CSF). The material has not been tested on children and pregnant or lactating women. Rx Only. For safe and proper use of this device, refer to the full Instructions for Use. Important Risk Information for HEMOBLAST™ Bellows Laparoscopic Applicator: Do not use the applicator to manipulate or retract organs or tissue. The product must be manipulated and used by qualified personnel according to the general principles of sterility and pre-medication. The tip of the laparoscopic applicator must be directly visualized at all times to minimize potential for unintended contact with tissue, organs, or blood as well as any possible unintended spillage of residual powder. Rx Only: For safe and proper use of this device, please refer to full device Instructions for Use. The trademark of HEMOBLAST™ Bellows and SPOT GRADE™ are the property of Dilon Technologies, Inc. The trademarks of the products listed herein are trademarks of their respective manufacturer. Please refer to the Instructions for Use accompanying each device for further information. HEM-098-V2_052523 ORDER HEMOBLAST BELLOWS TM HIGH-PERFORMANCE HEMOSTASIS MADE SIMPLE. HEMOBLAST™ Bellows is supplied as a preloaded bellows that: Contains 1.65 g of powder, including a maximum of 1,500 units of thrombin Includes a 10 cm nozzle extension to assist with application where a slightly longer tip is desired to reach the target bleeding site in open procedures Is biocompatible and non-pyrogenic MORE VERSATILITY FOR MORE APPLICATIONS The HEMOBLAST™ Bellows Laparoscopic Applicator is: Intended for delivering HEMOBLAST™ Bellows hemostatic powder to bleeding surgical sites Compatible with a 5 mm diameter or larger trocar Sold separately from HEMOBLAST™ Bellows* *Please see the HEMOBLAST™ Bellows and HEMOBLAST™ Bellows Laparoscopic Applicator Instructions for Use for complete information on the hemostatic agent. PART NUMBER DESCRIPTION MINIMUM ORDER QTY B Q F02-US 1 ea. HEMOBL AST ™ Bellows and 1 ea. 10 cm Nozzle Extension 1 case/12 ea. L A P01-US 1 ea. Individually Packaged Laparoscopic Applicator 1 case/12 ea. REQUEST A CLINICAL EVALUATION OR ORDER HEMOBLAST™ BELLOWS: DEMONSTRATION: 1-877-GO-DILON (1-877-463-4566) 1-877-GO-DILON (1-877-463-4566) dilon.com/hemoblast [email protected] Caution: Federal law restricts this device to sale on or by the order of a physician. Important Risk Information for HEMOBLAST™ Bellows: Do not inject HEMOBLAST™ Bellows into a vessel or tissue. There is a risk of allergic-anaphylactoid reaction and/or thromboembolic events, which may be life-threatening. Do not apply HEMOBLAST™ Bellows in the absence of active blood flow, e.g., while the vessel is clamped or bypassed. Extensive intravascular clotting and even death may result. Do not administer to patients with known allergies or hypersensitivity to materials of porcine or bovine origin. Because HEMOBLAST™ Bellows is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. HEMOBLAST™ Bellows contains chondroitin sulfate from bovine origin which is associated with a remote risk for Transmissible Spongiform Encephalopathies (TSE), which has been minimized in accordance with regulatory guidelines by a manufacturing process with demonstrated TSE inactivation capacity. When applied to a bleeding site, HEMOBLAST™ Bellows swells up to 60% within about 5 minutes. Do not attempt to trim the applicator tip. HEMOBLAST™ Bellows should not be used at the site of a valve replacement or repair as valvular dysfunction could occur. HEMOBLAST™ Bellows should not be applied at the site of a synthetic graft or patch implant due to potential for decreased effectiveness. The product should not be in contact with circulating cerebrospinal fluid (CSF). The material has not been tested on children and pregnant or lactating women. Rx Only. For safe and proper use of this device, refer to the full Instructions for Use. Important Risk Information for HEMOBLAST™ Bellows Laparoscopic Applicator: Do not use the applicator to manipulate or retract organs or tissue. The product must be manipulated and used by qualified personnel according to the general principles of sterility and pre-medication. The tip of the laparoscopic applicator must be directly visualized at all times to minimize potential for unintended contact with tissue, organs, or blood as well as any possible unintended spillage of residual powder. Rx Only: For safe and proper use of this device, please refer to full device Instructions for Use. The trademark of HEMOBLAST™ Bellows and SPOT GRADE™ are the property of Dilon Technologies, Inc. The trademarks of the products listed herein are trademarks of their respective manufacturer. Please refer to the Instructions for Use accompanying each device for further information. HEM-042-V3_052523  The Use of Hemostatic Agents to Decrease Bleeding Complications in Breast Cancer Surgery Introduction: Following breast cancer surgery, patients often require adjuvant radiation and chemotherapy for locoregional and systemic disease control. These procedures may result in postoperative complications, which may delay adjuvant therapy. To potentially decrease these complications, hemostatic agents may be used. This study evaluated the rate of postoperative bleeding complications and duration of Jackson-Pratt (JP) drain use in oncologic breast surgery with and without hemostatic agents. Results: The use of a hemostatic agent resulted in fewer bleeding complications and significantly decreased time until JP drain removal. Although not significant, subgroup analysis demonstrated that this was more pronounced in the CP group. JP drain duration was decreased among all procedures for CP compared to FS. 50 Duration of Time to 45 Jackson-Pratt Drain 40 Removal * = Statistically significant as compared to no hemostatic agent # = Statistically significant as compared to EVICEL® (FS) 35 30.4 Days with JP Drain 30 25 20 17.6 17.3 14.8 15 12.7 11.4 11.0 *, # * * 10 5.0 5 2.0 0 Oncoplastic Mastectomy Expander Exchange No Hemostatic Agent EVICEL® (FS) HEMOBLAST™ Bellows (CP) No Hemostatic Agent EVICEL® (FS) HEMOBLAST™ Bellows (CP) Oncoplastic Mastectomy Expander Oncoplastic Mastectomy Expander Oncoplastic Mastectomy Expander exchange exchange exchange N 87 23 40 73 28 5 29 23 7 Average follow-up 7.9 15.3 6.0 7.4 8.5 5.4 4.8 6.3 3.9 (weeks) Average time with JP 11.4 30.4 14.8 11.0 17.6 17.3 5.0 12.7 2.0 (days) Standard 4.5 16.5 12.6 5.3 14.4 10.7 4.1 7.2 3.4 deviation To access the article, click the link below or scan the QR code: The Use of Hemostatic Agents to Decrease Bleeding Complications in Breast Cancer Surgery Do not inject HEMOBLAST™ Bellows into a vessel or tissue or in the absence of active blood flow. The complete listing of Important Safety Information can be reviewed at: https://dilon.com/wp-content/uploads/2022/10/hemoblast-bellows-instructions-for-use.pdf HEMOSTATIC AGENT BLEEDING INDICATIONS HEMOBLAST™ Bellows is the only product indicated as an adjunct to hemostasis for minimal, mild, and moderate bleeding based on the SPOT GRADE™ (Surface Bleeding Severity Scale).1-14 Surface Bleeding Severity Scale (SBSS) No Descriptor Capillary, Venous, Oozing Blood and of Bleeding and Arteriolar Minor Bleeding7,8 Minimal Mild Moderate Severity3,9-14 Bleeding1,2,4-8 (Oozing)1 (Pooling)1 (Flowing)1 Combination Powdered Hemostats Mechanical Hemostats* ARISTA™ AH AVITENE™ GELFOAM® POWDER SURGICEL® POWDER SURGIFOAM® POWDER Topical Thrombin* RECOTHROM® THROMBIN-JMI® Flowables† FLOSEAL® SURGIFLO® Fibrin Sealants† TISSEEL® EVICEL® Fibrin Sealant Patches† EVARREST® TACHOSIL® * Products are indicated for adjunctive hemostasis of capillary, venous, small artery, and/or arteriolar bleeding. † Products are indicated for adjunctive hemostasis when control of bleeding by conventional methods is ineffective or impractical. 1. HEMOBLAST™ Bellows Hemostatic Agent [Instructions for Use]. Dilon Technologies, Inc. 2. ARISTA™ AH Absorbable Hemostatic Particles Instructions for Use. CR Bard, Inc. 3. Avitene™ Microfibrillar Collagen Hemostat [Instructions for Use]. CR Bard, Inc. 4. Gelfoam® Absorbable Gelatin Powder [Instructions for Use] Pharmacia and Upjohn Co. 5. SURGICEL® Powder Absorbable Hemostat. Ethicon, www.ethicon.com/na/ products/adjunctive-hemostasis/absorbable-hemostats/surgicel-powder-absorbable-hemostat. Accessed August 22, 2018. 6. SURGIFOAM® Absorbable Gelatin Powder Package Insert. Somerville NJ; Ethicon Inc. 7. RECOTHROM® [Package Insert]. Hazelwood, MO: Mallinckrodt Hospital Products Inc; 2016. 8. THROMBIN-JMI® [Prescribing Information]. New York, NY; Pfizer Inc; 2018. 9. FLOSEAL® Hemostatic Matrix [Instructions for Use]. Deerfield, IL: Baxter Healthcare. 10. SURGIFLO® Hemostatic Matrix Kit [Instructions for Use]. Somerville, NJ; Ethicon Inc. 11. TISSEEL® Fibrin Sealant [Prescribing Information]. Deerfield, IL: Baxter Healthcare. 12. EVICEL® Fibrin Sealant [Prescribing Information]. Somerville NJ; Ethicon Inc. 13. EVARREST® Fibrin Sealant Patch [Prescribing Information]. Somerville, NJ; Ethicon Inc. 14. TachoSil® Fibrin Sealant Patch [Prescribing Information]. Takeda AS. HEMOSTATIC AGENT INDICATIONS Indications Combined Powdered Hemostats HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures. Mechanical Hemostats ARISTA™ AH is indicated in surgical procedures (except neurological and ophthalmic) as an adjunctive hemostatic device to assist when control of ARISTA™ AH capillary, venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. AVITENE™ (MCH) is used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is AVITENE™ ineffective or impractical. GELFOAM® Sterile Powder, saturated with sterile sodium chloride solution, is indicated in surgical procedures, including those involving cancellous GELFOAM® POWDER bone bleeding, as a hemostatic device, when control of capillary venous, and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. Although not necessary, GELFOAM® can be used either with or without thrombin to obtain hemostasis. SURGICEL® Powder (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small SURGICEL® POWDER arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGIFOAM® Powder saturated with sterile sodium chloride solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when SURGIFOAM® POWDER control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. Although not necessary, SURGIFOAM® Powder can be used with thrombin to achieve hemostasis. Topical Thrombin RECOTHROM®, Thrombin topical (Recombinant), is a topical thrombin indicated to aid hemostasis whenever oozing blood and minor bleeding from RECOTHROM® capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. THROMBIN-JMI® THROMBIN-JMI® is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible. Flowables FLOSEAL® Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or FLOSEAL® conventional procedures is ineffective or impractical. SURGIFLO® Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct SURGIFLO® to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. Fibrin Sealants Hemostasis: TISSEEL® is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL® TISSEEL® is effective in heparinized patients. Sealing: TISSEEL® is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. EVICEL® is a fibrin sealant (human) indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard EVICEL® surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Fibrin Sealant Patches EVARREST® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. Limitations for Use: Cannot EVARREST® be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding. Not for use in children under one month of age. Not for use in laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve. TACHOSIL®: Indicated for use with manual compression in adult and pediatric patients as an adjunct to hemostasis in cardiovascular and hepatic TACHOSIL® surgery when control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. Not for use in place of sutures or other forms of mechanical ligation in treatment of major arterial or venous bleeding. Not for use in children under one month of age. Indication: HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures. Important Risk Information for HEMOBLAST™ Bellows: Do not inject HEMOBLAST™ Bellows into a vessel or tissue. There is a risk of allergic-anaphylactoid reaction and/or thromboembolic events, which may be life- threatening. Do not apply HEMOBLAST™ Bellows in the absence of active blood flow, e.g., while the vessel is clamped or bypassed. Extensive intravascular clotting and even death may result. Do not administer to patients with known allergies or hypersensitivity to materials of porcine or bovine origin. Because HEMOBLAST™ Bellows is made from human blood, it may carry a risk oftransmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. HEMOBLAST™ Bellows contains chondroitin sulfate from bovine origin which is associated with a remote risk for Transmissible Spongiform Encephalopathies (TSE), which has been minimized in accordance with regulatory guidelines by a manufacturing process with demonstrated TSE inactivation capacity. When applied to a bleeding site, HEMOBLAST™ Bellows swells up to 60% within about 5 minutes. Do not attempt to trim the applicator tip. HEMOBLAST™ Bellows should not be used at the site of a valve replacement or repair as valvular dysfunction could occur. HEMOBLAST™ Bellows should not be applied at the site of a synthetic graft or patch implant due to potential for decreased effectiveness. The product should not be in contact with circulating cerebrospinal fluid (CSF). The material has not been tested on children and pregnant or lactating women. Rx Only. Important Safety Information for the Laparoscopic Applicator: Do not use the applicator to manipulate or retract organs or tissue. The product must be manipulated and used by qualified personnel according to the general principles of sterility and pre-medication. The tip of the laparoscopic applicator must be directly visualized at all times to minimize potential for unintended contact with tissue, organs, or blood as well as any possible unintended spillage of residual powder. This material is intended for Health Care Professionals in the U.S. Please refer to the Instructions for Use accompanying each device for further information. Caution: Federal law restricts this device to sale on or by the order of a physician. The trademark of HEMOBLAST™ Bellows and SPOT GRADE™ are the property of Dilon Technologies, Inc. The trademarks of the products listed herein are trademarks of their respective manufacturer. Copyright © 2019 Dilon Technologies, Inc. HEM-048-V3_052523 DOI: 10.1111/jocs.13982 NEW TECHNOLOGIES Evaluation of the safety and efficacy of a new hemostatic powder using a quantitative surface bleeding severity scale Abbas Ardehali MD1 | William D. Spotnitz MD2,3 | Rachel W. Hoffman BSE4 | Steven A. Olson MD5 | Grant V. Bochicchio MD6 | Mark C. Hermann MD7 | Shankar Lakshman MD8 | Nick C. Dang MD9 | Valerie Centis PhD10 | Dan L. Gillen PhD11 | Ian J. Schorn BSE4 | Russell H. Spotnitz MD3 | the Advanced Powder Investigators Group (APIG)12 1 Department of Surgery, University of California at Los Angeles, Los Angeles, Abstract California Aims of the study: The safety and efficacy of a hemostatic powder (HP) versus a control 2 Department of Surgery, University of Virginia, Charlottesville, Virginia agent, absorbable gelatin sponge and thrombin (G + T), were assessed, using a 3 Department of Medical Affairs, Biom’up, validated, quantitative bleeding severity scale. Lyon, France Methods: Subjects were randomized to receive HP (256 subjects) or G + T (132 4 NAMSA, Clinical and Consulting, Minneapolis, Minnesota subjects) for treatment of minimal, mild, or moderate bleeding at 20 investigational 5 Department of Orthopaedic Surgery, Duke sites. The primary efficacy endpoint was non-inferiority of HP relative to G + T for University School of Medicine, Durham, North success at achieving hemostasis within 6 minutes. Secondary endpoints in rank order Carolina 6 Department included: superiority of HP relative to G + T in mean preparation time; non-inferiority of of Surgery, Washington University School of Medicine, St. Louis, HP relative to G + T for achieving hemostasis within 3 min; superiority of HP relative to Missouri Advanced Powder Investigators Group (APIG) Members: Gorav Ailawadi, MD, TCV Surgery, University of Virginia, Charlottesville, VA; Michael Argenziano, MD, Adult Cardiac Surgery Section, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Guarav Bharti, MD, Plastic Surgery, Hunstad Kortesis Bharti Cosmetic Surgery, Huntersville, NC; Michael A. Borger, MD, Aortic Surgery Section, New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; William C. Chapman, MD, Section of Transplantation, Washington University School of Medicine, St. Louis, MO; Philip C. Corcoran, MD, Cardiothoracic Surgery, NIH Heart Center at Suburban Hospital, Bethesda, MD; Mani A. Daneshmand, MD, Cardiothoracic Surgery, Duke University Medical Center, Durham, NC; Daniel J. Del Gaizo, MD, Department of Orthopaedic Surgery, University of North Carolina School of Medicine, Chapel Hill, NC; Joseph P. DeSimone, MD, and Anthony W. DiScipio, MD, Department of Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; Maria Bernadette Majella Doyle, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Yuri S. Genyk, MD, Division of Hepatobiliary/Pancreatic Surgery and Abdominal Organ Transplantation, Keck School of Medicine, University of Southern California, Los Angeles, CA; Keith A. Horvath, MD, Cardiothoracic Surgery, NIH Heart Center at Suburban Hospital, Bethesda, MD; Joseph P. Hunstad, MD, Plastic Surgery, Hunstad Kortesis Bharti Cosmetic Surgery, Huntersville, NC; Kareem Daniel Husain, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Obeid N. Ilahi, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Alexander Iribarne, MD, Department of Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; Michael E. Kelly, MD, Miami Plastic Surgery, Miami, FL; Bill G. Kortesis, MD, Plastic Surgery, Hunstad Kortesis Bharti Cosmetic Surgery, Huntersville, NC; Jeffrey M. Lau, MD, Department of Cardiovascular Medicine, The Queen's Medical Center, Honolulu, HI; Brian D. Lewis, MD, Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC; John S. Mahoney, MD, General Orthopedics and Surgery, Spectrum Medical, Danville, VA; Jock N. McCullough, MD, Department of Surgery, Dartmouth Hitchcock Medical Center, Lebanon, NH; Marc R. Moon, MD, Division of Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, MO; Steven L. Myerthall, MD, Orthopedic Surgery, Center for Orthopedic Research and Education, Gilbert, AZ; Nadia M. Obeid, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Max Polo, MD, Plastic Surgery, Miami Plastic Surgery, Miami, FL; Laurie J. Punch, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Ramachandra C. Reddy, MD, Thoracic Surgery, Mount Sinai School of Medicine, New York, NY; Jose Rodriguez-Feliz, MD, Plastic Surgery, Miami Plastic Surgery, Miami, FL; Jacob N. Schroder, MD, Cardiothoracic Surgery, Duke University Medical Center, Durham, NC; Douglas J.E. Schuerer, MD, Department of Surgery, Washington University School of Medicine, St. Louis, MO; Linda S. Sher, MD, Division of Hepatobiliary/Pancreatic Surgery and Abdominal Organ Transplantation, Keck School of Medicine, University of Southern California, Los Angeles, CA; Ivan R. Zendejas-Ruiz, MD, General Surgery, Intermountain Medical Center, Murray, UT. TRIAL REGISTRATION HEMOBLAST Bellows Pivotal Clinical Investigation; clinicaltrials.gov identifier NCT02780869; https://clinicaltrials.gov/ct2/show/NCT02780869 This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. © 2019 The Authors. Journal of Cardiac Surgery Published by Wiley Periodicals, Inc. J Card Surg. 2019;1–13. wileyonlinelibrary.com/journal/jocs | 1 2 | ARDEHALI ET AL. 7 GeneralOrthopedics and Surgery, Spectrum G + T for achieving hemostasis within 6 min; and superiority of HP relative to G + T for Medical, Danville, Virginia 8 Department of Surgery, Huntington Hospital, success for achieving hemostasis within 3 min. Pasadena, California Results: A total of 388 subjects were included in the primary efficacy analysis. At 6 min, 9 Department of Surgery, Queens Hospital, hemostasis was achieved in 93.0% (238/256) of the HP group compared to 77.3% Honolulu, Hawaii 10 Department of Research and Development, (102/132) of the G + T group (non-inferiority P < 0.0001, superiority P < 0.0001). All Biom’up, Lyon, France secondary endpoints were met. Complications were comparable between treatment 11 Department of Statistics, Department of groups. Epidemiology, University of California at Irvine, Irvine, California Conclusions: HP had superior rates of hemostasis, shorter preparation time, and a 12 Advanced Powder Investigators Group similar safety profile compared to G + T in this prospective, randomized trial using (APIG) quantitative bleeding severity criteria. Correspondence William D. Spotnitz MD, MBA, 2738 SW 92nd KEYWORDS Drive, Gainesville, FL 32608. bleeding scale, collagen, hemostat, hemostatic agent, hemostatic powder, thrombin Email: [email protected] Funding information Biom'up 1 | INTRODUCTION Subjects 21 years and older undergoing non-emergent cardiotho- racic, abdominal, and lower extremity orthopedic operations were Level I evidence of the benefit of local hemostats in surgical operations evaluated after providing written informed consent. Subjects were is limited, yet research in this area is continuing to grow.1–39 Although excluded if they met the following criteria: undergoing laparoscopic, the ideal surgical hemostat—one combining safety, efficacy, usability, thoracoscopic, robotic, neurologic, spinal, or emergency surgery; cost, and approvability—has yet to be created, continued development pregnant, planning on becoming pregnant during the follow-up period, work is resulting in new agents.40–42 or actively breast-feeding; platelet count 1.5 within 4 weeks of surgery; receiving intravenous efficacy of a novel hemostatic powder (HP) containing collagen, heparin 12 hr prior to surgery or oral warfarin 2 days prior to surgery; chondroitin sulfate, and thrombin compared to an established receiving antiplatelet medications within 5 days of surgery or aspirin absorbable gelatin sponge and thrombin hemostatic agent.43 This within 7 days of surgery (exception: cardiothoracic subjects could receive multicenter trial compared efficacy based on levels of bleeding using a aspirin at any time before surgery); active or suspected infection at the unique, validated, quantitative surface bleeding severity scale (SBSS), surgical site; planned to receive organ transplantation; known sensitivity the SPOT GRADE.44 This SBSS is a bleeding severity scale based on or allergy to bovine and/or porcine substance(s) or any other component- quantitative measures that has been specifically validated in a clinical (s) of the hemostat; American Society of Anesthesiologists classification of setting.45 Other bleeding severity scales are based on qualitative 5; life expectancy 1 month of age) undergoing surgery, when control bleeding by conventional undergoing surgery when control of of bleeding by standard surgical procedures is ineffective or bleeding by conventional surgical techniques (such as suture, ligature impractical, except in techniques (such as suture, ligature, or cautery) is ineffective or neurosurgical, ophthalmic, and and cautery) is ineffective or impractical. urological procedures. impractical. TISSEEL is effective in heparinized patients. Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies. PREPARATION No mixing, thawing, or heating 2 mL and 4 mL syringes can be Thaw time: thawed in 5 minutes in sterile water 10 minutes at 37° C bath; 10 mL in 12 minutes 1 hour at room temperature NOTE: time is longer if non sterile water bath is used 1 day in refrigerator 2°C - 8°C TIME TO HEMOSTASIS 71% achieved hemostasis in 88.2% achieved hemostasis within 5 Retroperitoneal and intra- 3 minutes (cardiothoracic, minutes and maintained until abdominal: 75.8% in 4 minutes abdominal, and lower surgical closure Vascular: 83.3% achieved extremity surgeries) hemostasis in 4 minutes 89% hemostasis for moderate Liver: 5.3 minutes average time to bleeding by 6 minutes8 hemostasis AVAILABLE SIZES 1.65 g 2 mL, 4mL, and 10 mL 2 mL, 4 mL, and 10 mL PRODUCT COVERAGE Up to 50 cm2 per bellows area When sprayed: With cannula: Maximum coverage for 1 mm covered 2 mL =100 cm2 2 mL =8 cm2 thickness when sprayed 4 mL = 200 cm2 4 mL = 16 cm2 2 mL = 20 cm2 10 mL = 500 cm2 10 mL = 40 cm2 4 mL = 40 cm2 10 mL = 100 cm2 REMOVAL / Excess powder removed by gentle Not required Not required IRRIGATION irrigation (ONCE HEMOSTASIS IS ACHIEVED) TIME USE LIMITS Can be used throughout the Use within 4 hours of thawing Can be stored frozen or WHEN PREPARED duration of the operation without Unopened pouches can be refrigerated any known or reported hazards stored for up to 48 hours at room Up to 30 days at 2°C - 8°C temperature (15-25°C) (refrigerated temperature) once thawed Cannot be refrozen Within 24 hours after being brought to room temperature USE IN PEDIATRIC Has not been clinically evaluated Children >1 month of age, limited Above 6 months in age PATIENTS data PRODUCT SWELL Maximum swell volume (60%) is Does not swell Does not swell achieved in about 5 minutes RESORPTION Resorbed within 4 weeks Resorbed in 10 to 14 days Days to weeks LAPAROSCOPIC USE Laparoscopic applicator not Yes; multiple devices and tips Yes; multiple lengths available THROMBIN available forofsale in the US 1,600 - 2,500 IU/4 mL 1,600 – 2,400 IU/4 mL Maximum 1,500 IU/bellows AMOUNTS (400 – 625 IU/mL) (800-1,200 IU/mL) This document is intended for internal educational use only and shall not be distributed or discussed outside of Biom’up. The trademark of HEMOBLAST™ Bellows and SPOT GRADE™ are the property of Biom’up. The trademarks of the products listed herein are trademarks of their respective manufacturer. Please refer to the Instructions for Use accompanying each device for further information REFERENCES 1. TISSEEL Fibrin Sealant [prescribing information]. Deerfield, IL: Baxter Healthcare. 2. Evicel Fibrin Sealant [prescribing information]. Somerville NJ; Ethicon Inc. 3. www.tisseel.com/us. Accessed February 28, 2018. 4. http://www.ethicon.com/healthcare-professionals/products/biosurgery/evicel-fibrin-sealant-human. Accessed February 28, 2018. 5. Evicel brochure. 031152-151109. 2015. Somerville NJ; Ethicon Inc. 6. 2016 IMS Hemostat Revenue, Unit, and ASP Sales Data. 7. HEMOBLAST Bellows Hemostatic Agent [instructions for use]. Biom’up SA. 8. HEMOBLAST™ Bellows pivotal study clinical study report (CSR) on file at Biom’up. FOR INTERNAL USE ONLY  COMPETITIVE PRIMERS FIBRIN FIBRIN GELATIN FLOWABLES SEALANT ARISTA SURGICEL AVITENE SEALANTS +THROMBIN PATCHES WHAT IS A FIBRIN SEALANT PATCH? What are they made from? These are pads that are coated on one side with a dry layer of lyophilized human plasma components fibrinogen and thrombin. TACHOSIL® (licensed by Baxter in US) is an equine collagen sponge that contains riboflavin as a yellow colorant to signify the active side. It is stiff and flaky when dry and typically rinsed with saline before application to make it more pliable.1 EVARREST® (J&J Ethicon) contains a layer of oxidized regenerated TACHOSIL8 cellulose (the same material as SURGICEL) underlaying a layer of nonwoven polyglactin 910 (PG910) fibers (material used in the manufacture of Coated VICRYL Suture) and contains significantly more thrombin than TACHOSIL (nearly 20x),1,2 which may explain why it is noticeably more powdery. It is thicker than TACHOSIL Patch but is softer and more flexible when dry. How do they work? Upon contact with blood, the thrombin/fibrinogen initiates the last step of coagulation cascade to form a fibrin clot. The pads can be left in EVARREST 4 place.1,2 NOTE: J&J has focused on selling EVARREST in trauma surgery, where the expense appears to be more justifiable in emergent situations of bleeding. TACHOSIL Messaging3 EVARREST Messaging4 “A BioLOGICAL Hemostatic Choice” An innovative solution that can stop problematic bleeding on the 1st attempt Ready-to-use EVARREST Innovation offers superior hemostatic efficacy Conformable - Maintains flexibility that on the 1st attempt accommodates tissue and organ movement Ready to use, right out of the box Staying Power - High adhesive strength shown to withstand pressures up to 61.4 hPa (46.1 mmHg) AVERAGE PRICING:5 $450 for TACHOSIL, $800-1,100 for EVARREST HEMOBLAST™ TACHOSIL1 EVARREST2 Bellows6 ✓ ✓ ✓ Ready-to-use, no preparation time ✓ ✓ ✓ Stored at room temperature ✓ Can be sprayed to cover large area bleeding ✓ Clinically proven on a validated bleeding scale ✓ Bulky ✓ Can be used in laparoscopic procedures* ✓ ✓ Limit to the amount of product that can be used ✓ ✓ Twice the cost on average per unit5 *Lap applicator for HEMOBLAST™ Bellows expected in 2018. Not to be discussed with customers. FOR INTERNAL USE ONLY  COMPETITIVE PRIMERS FIBRIN FIBRIN GELATIN FLOWABLES SEALANT ARISTA SURGICEL AVITENE SEALANTS +THROMBIN PATCHES HEMOBLAST™ BELLOWS POSITIONING HEMOBLAST™ Bellows provides high-performance hemostasis cost-effectively, and still offers the convenience and versatility of a ready-to-use powder. There is no limit to the amount of product that can be used. HEMOBLAST™ T A C H O S I L ®1 E V A R R E S T ®2 Bellows6 INDICATION HEMOBLAST™ Bellows is indicated in Indicated for use with manual EVARREST is a fibrin sealant patch surgical procedures as an adjunct to compression in adult and pediatric indicated for use with manual hemostasis when control of minimal, patients as an adjunct to hemostasis in compression as an adjunct to hemostasis mild, and moderate bleeding by cardiovascular and hepatic surgery in adult patients undergoing surgery, conventional procedures is ineffective or when control of bleeding by standard when control of bleeding by impractical, except in neurosurgical, surgical techniques (such as suture, conventional surgical techniques (such ophthalmic, and urological procedures. ligature or cautery) is ineffective or as suture, ligature, and cautery) is impractical. ineffective or impractical. Limitations for Limitations for use: Not for use in place of Use: Cannot be used in place of sutures sutures or other forms of mechanical or other forms of mechanical ligation in ligation in treatment of major arterial or the treatment of major arterial or venous venous bleeding. Not for use in children bleeding. Not for use in children under under one month of age. one month of age. Not for use in laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve. TIME TO HEMOSTASIS 71% achieved hemostasis in 75% achieved hemostasis in 3 92.3% achieved hemostasis in 3 3 minutes (cardiothoracic, minutes; 95% achieved hemostasis in minutes (cardiovascular) abdominal, and lower 6 minutes (cardiovascular) extremity surgeries) 81% achieved hemostasis in 3 89% hemostasis for moderate minutes; 95% achieved hemostasis in bleeding by 6 minutes7 5 minutes (hepatic) AVAILABLE SIZES 1.65 g 1.2 in x 1.0 in (3.0 cm x 2.5 cm) 2 - 2 in x 4 in (5.1 cm x 10.2 cm) 1.9 in x 1.9 in (4.8 cm x 4.8 cm) 1 - 4 in x 4 in (10.2 cm x 10.2 cm) 3.7 in x 1.9 in (9.5 cm x 4.8 cm) PRODUCT COVERAGE Up to 50 cm2 per bellows area covered 7 in2 / 45.6 cm2 maximum with largest 8 in2 or 103 cm2 with largest pad; up to 4 patch; up to 10 patches may be applied patches may be used at this size of this size REMOVAL / Excess powder removed by gentle Not mandatory Not mandatory IRRIGATION irrigation (ONCE HEMOSTASIS IS ACHIEVED) TIME USE LIMITS Can be used throughout the duration of Not stated in IFU Not stated in IFU WHEN PREPARED the operation without any known or reported hazards USE IN PEDIATRIC Has not been clinically evaluated Greater than 1 month No study data available PATIENTS PRODUCT SWELL Maximum swell volume (60%) is achieved Does not swell Amount not mentioned in about 5 minutes RESORPTION Resorbed within 4 weeks Remnants of the patch may remain 8 weeks (10% remnants remaining) present up to 12 months LAPAROSCOPIC USE Laparoscopic applicator not available No specific lap indication Limitation for use: Laparoscopic and for sale in the US NOTE: some surgeons will moisten, roll it other minimally invasive surgeries where up and put down trocar manual compression would be difficult to achieve. THROMBIN 123.1 IU/3.7 in x 1.9 in patch 1,935.2 IU/ 2 in x 4 in patch Maximum of 1,500 IU/bellows AMOUNTS (12.9 IU/in2) (241.9 IU/in2) This document is intended for internal educational use only and shall not be distributed or discussed outside of Biom'up. The trademark of HEMOBLAST™ Bellows and SPOT GRADE™ are the property of Biom’up. The trademarks of the products listed herein are trademarks of their respective manufacturer. Please refer to the Instructions for Use accompanying each device for further information REFERENCES 1. TachoSil Fibrin Sealant Patch [prescribing information]. Takeda AS. 2. Evarrest Fibrin Sealant Patch [prescribing information]. Somerville, NJ; Ethicon Inc. 3. http://www.tachosilus.com/. Accessed February 28, 2018. 4. http://www.ethicon.com/healthcare-professionals/products/biosurgery/evarrest-fibrin-sealant-patch. Accessed December 5, 2017. 5. 2016 IMS Hemostat Revenue, Unit, and ASP Sales Data. 6. HEMOBLAST Bellows Hemostatic Agent [instructions for use]. Biom’up SA. 7. HEMOBLAST™ Bellows pivotal study clinical study report (CSR) on file at Biom’up. 8. https://www.medgadget.com/2010/04/bioresorbable_sealant_patch_gets_fda_approval.html. Accessed April 5, 2018. FOR INTERNAL USE ONLY  COMPETITIVE PRIMERS FIBRIN FIBRIN GELATIN FLOWABLES SEALANT ARISTA SURGICEL AVITENE SEALANTS +THROMBIN PATCHES WHAT IS ARISTA™? COAGULATION CASCADE COMPARISON What is it made from? BLOOD VESSEL A fine, dry, sterilized white powder. INJURY HEMOBLAST ARISTA Incorporates hydrophilic microporous particles synthesized Poly- by cross-linking purified plant starch (100% plant-based collagen saccharide polysaccharide).1 MECHANICAL spheres How does it work? Platelet aggregation The manufacturer claims their “proprietary MPH technology” FACTORS AFFECTED BY COAGULOPATHIES (Microporous Polysaccharide Hemospheres) consists of particles INT/EXT CLOTTING (creates Prothrombin which that are hydrophilic molecular sieves that enhance natural FACTORS is converted to thrombin) hemostasis by concentrating blood solids such as platelets, red blood cells, and blood proteins on the particle surfaces to form a thrombin Thrombin converts fibrinogen to fibrin gelled matrix.1 FIBRIN The concentrated gel matrix provides a barrier to further blood CLOTTING fibrinogen fibrin loss and is formed regardless of the patient’s coagulation status.1 NOTE: Although this is the manufacturer’s claim, without the Chondroitin presence of thrombin, a functioning clotting cascade is still sulfate STABLE CLOT required to create a stable clot (see chart on right). ARISTA Messaging2 Simple – no mixing, no refrigeration, simply pop the cap Safe – purified plant starch is thrombin-free Effective – clotting regardless of patient’s coagulation status, broad area coverage on rough surfaces and hard-to-reach areas NOTE: Manufacturer claims it is cell-saver safe. However, that is only with the 40 µm filter, not the 1,200 µm filter which is more common. AVERAGE PRICING:3 $95 for the 1 g, $200 for 3 g (most popular) and $265 for 5 g bellows A RI S TA 2 HEMOBLAST™ ARISTA1 Bellows4 ✓ ✓ Ready-to-use, no preparation time ✓ ✓ Stored at room temperature ✓ ✓ Easily applied over large area bleeding2 ✓ ✓ Can be applied in areas of focal bleeding2 ✓ Clinically proven on a validated bleeding scale ✓ Contains thrombin ✓ Can be used in laparoscopic procedures* ✓ ✓ Precaution for the use with cell savers *Lap applicator for HEMOBLAST™ Bellows expected in 2018. Not to be discussed with customers. FOR INTERNAL USE ONLY  COMPETITIVE PRIMERS FIBRIN FIBRIN GELATIN FLOWABLES SEALANT ARISTA SURGICEL AVITENE SEALANTS +THROMBIN PATCHES HEMOBLAST™ BELLOWS POSITIONING HEMOBLAST™ Bellows provides the ready-to-use convenience of ARISTA with the added benefit of thrombin, for proven efficacy up to moderate, or flowing bleeding. HEMOBLAST™ Bellows4 ARISTA™1 INDICATION HEMOBLAST™ Bellows is indicated in surgical ARISTA AH is indicated in surgical procedures (except procedures as an adjunct to hemostasis when neurological* and ophthalmic) as an adjunctive control of minimal, mild, and moderate bleeding by hemostatic device to assist when control of capillary, conventional procedures is ineffective or venous, and arteriolar bleeding by pressure, ligature, impractical, except in neurosurgical, ophthalmic, and other conventional procedures is ineffective or and urological procedures. impractical. *PMA approval for neurological use in 2016 TIME TO HEMOSTASIS 71% achieved hemostasis in 3 minutes Median time: 1 minute for orthopedic, 2 minutes for (cardiothoracic, abdominal, and lower cardiac and general extremity surgeries) 50.3% achieved hemostasis within 1 minute, 66.2% 89% hemostasis for moderate bleeding by within 2 minutes; 90.3% within 5 minutes 6 minutes5 AVAILABLE SIZES 1.65 g 1 g, 3 g, and 5 g ENT Kit available that Includes (1) 2 g HEMADERM™ and (2) FLEXITIP™ applicators PRODUCT Up to 50 cm2 per bellows area covered In the pivotal trial, surgeons used between COVERAGE approximately 1-9 grams to treat up to five bleeding lesions REMOVAL / Excess powder removed by gentle irrigation Irrigate and aspiration of excess (particularly when IRRIGATION used around foramina of bone, spine cord, and optic (ONCE HEMOSTASIS IS nerve and chiasm) ACHIEVED) TIME USE LIMITS Can be used throughout the duration of the operation Must be used immediately after opening applicator WHEN PREPARED without any known or reported hazards USE IN PEDIATRIC Has not been clinically evaluated Has not been clinically evaluated PATIENTS PRODUCT SWELL Maximum swell volume (60%)is achieved in about 5 Swells to maximum volume immediately upon contact minutes with blood or other fluids; up to five times original volume RESORPTION Resorbed within 4 weeks Within 24 to 48 hours LAPAROSCOPIC USE Laparoscopic applicator not available for sale in the US Yes This document is intended for internal educational use only and shall not be distributed or discussed outside of Biom'up. The trademark of HEMOBLAST™ Bellows, SPOT GRADE™ are the property of Biom’up. The trademarks of the products listed herein are trademarks of their respective manufacturer. Please refer to the Instructions for Use accompanying each device for further information REFERENCES 1. ARISTA AH Absorbable Hemostatic Particles Instructions for Use. CR Bard, Inc. 2. Arista AH brochure. DAV/ARS1/0615/0062. CR Bard, Inc. 3. 2016 IMS Hemostat Revenue, Unit, and ASP Sales Data. 4. HEMOBLAST Bellows Hemostatic Agent [instructions for use]. Biom’up SA. 5. HEMOBLAST™ Bellows pivotal study clinical study report (CSR) on file at Biom’up. FOR INTERNAL USE ONLY  COMPETITIVE PRIMERS FIBRIN FIBRIN GELATIN FLOWABLES SEALANT ARISTA SURGICEL AVITENE SEALANTS +THROMBIN PATCHES WHAT IS A SURGICEL®? COAGULATION CASCADE COMPARISON What is it made from? BLOOD VESSEL HEMOBLAST SURGICEL INJURY A pad made of oxidized regenerated cellulose (ORC), which is a plant-based material.1 collagen cellulose Available as a powder or pad (four forms available as MECHANICAL detailed below). Platelet aggregation It was first introduced in 1947 and has become the most widely FACTORS AFFECTED BY COAGULOPATHIES used hemostat on the market. INT/EXT CLOTTING (creates Prothrombin which is converted to thrombin) FACTORS How does it work? thrombin Thrombin converts The mechanism of action is not completely understood, but it fibrinogen to fibrin appears to be a physical effect rather than any alteration of the FIBRIN CLOTTING normal physiologic clotting mechanism.1 fibrinogen fibrin Its hemostatic effect is not enhanced by the addition of thrombin, the activity of which is destroyed by the low pH of the product. The Chondroitin sulfate STABLE CLOT manufacturer claims this low pH provides antibacterial benefits.1 ORIGINAL2 N U - K N I T 1,3 Fibrillar4 SNoW5 Powder6 Loose knit Densely woven knit Soft lightweight, layered Structured Non-Woven Aggregate of small ORC Wraps well and allows Better for ORC Material fiber fragments visibility heavy bleeding Layers easily Enhanced Efficiently and Current market leader; Designed to hold separate/peel off to conformability and effectively controls dominates the low-end a suture use amount wanted adherence to continuous oozing on hemostat market 3x stronger than “Melts” into bleeding bleeding site broad surfaces Original tissue compared to Original Precise delivery control 33% faster hemostasis 43% faster hemostasis regardless of device than Original than Original orientation AVERAGE PRICING:7 $30-$50 for Original, $60-$150 for others depending on the size of pad HEMOBLAST™ S U R G I C E L 1,6 Bellows8 ✓ ✓ Ready-to-use, no preparation time ✓ ✓ Stored at room temperature ✓ POWDER ONLY Can be sprayed to cover large area bleeding6 ✓ ✓ Can be applied in areas of focal bleeding ✓ Clinically proven on a validated bleeding scale ✓ Contains thrombin ✓ Denatures thrombin ✓ Reports of burning or stinging when used as packing or applied on surface wounds (due to low pH) ✓ Has bactericidal properties FOR INTERNAL USE ONLY  COMPETITIVE PRIMERS FIBRIN FIBRIN GELATIN FLOWABLES SEALANT ARISTA SURGICEL AVITENE SEALANTS +THROMBIN PATCHES HEMOBLAST™ BELLOWS POSITIONING HEMOBLAST™ Bellows provides the ready-to-use convenience of SURGICEL with the added benefit of thrombin for hemostasis that’s proven effective up to moderate, or flowing bleeding. HEMOBLAST™ Bellows8 S U R G I C E L ®1 INDICATION HEMOBLAST™ Bellows is indicated in surgical SURGICEL® Absorbable Hemostat (oxidized procedures as an adjunct to hemostasis when regenerated cellulose) is used adjunctively in surgical control of minimal, mild, and moderate bleeding by procedures to assist in the control of capillary, venous, conventional procedures is ineffective or and small arterial hemorrhage when ligation or other impractical, except in neurosurgical, ophthalmic, conventional methods of control are impractical or and urological procedures. ineffective. SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™, SURGICEL® SNoW and SURGICEL® NU-KNIT® Hemostats can be cut to size for use in endoscopic procedures. 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.6 TIME TO HEMOSTASIS 71% achieved hemostasis in 3 minutes “Fast hemostasis”, no time data in package insert (cardiothoracic, abdominal, and lower extremity surgeries) 89% hemostasis for moderate bleeding by 6 minutes9 AVAILABLE SIZES 1.65 g SURGICEL Original 5.1 x 1.3 cm, 5.1 x 7.6 cm, 10.2 x 20.3 cm, 5.1 x 35.6 cm SURGICEL Nu-Knit 2.5 x 2.5 cm, 2.5 x 8.9 cm, 7.6 x 10.2 cm, 15.2 x 22.9 cm SURGICEL Fibrillar 2.5 x 5.1 cm, 5.1 x 10.2 cm, 10.2 x 10.2 cm SURGICEL SNoW5 2.5 x 5.1 cm, 5.1 x 10.2 cm, 10.2 x 10.2 cm SURGICEL Powder:6 3.0 grams per unit PRODUCT Up to 50 cm2 per bellows area covered See available sizes above, may be cut to size COVERAGE SURGICEL Powder: “Broad coverage”6 REMOVAL / Excess powder removed by gentle irrigation Original, Nu-Knit, Fibrillar, and SNoW formulations of IRRIGATION SURGICEL should be removed after hemostasis is (ONCE HEMOSTASIS IS achieved ACHIEVED) Irrigate excess SURGICEL Powder6 TIME USE LIMITS Can be used throughout the duration of the operation Not specified in IFU WHEN PREPARED without any known or reported hazards USE IN PEDIATRIC Has not been clinically evaluated Not specified in IFU PATIENTS PRODUCT SWELL Maximum swell volume (60%) is achieved in about 5 Yes, but amount not specified in IFU minutes RESORPTION Resorbed within 4 weeks