THE ONLY PRODUCT INDICATED AS AN ADJUNCT TO HEMOSTASIS FOR MINIMAL, MILD, AND MODERATE BLEEDING1-13

Biom’up developed the SPOT GRADE™ scale also known as 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, receiving indications for the control of SPOT GRADE™ bleed levels 1 through 3, covering oozing to flowing bleeding.1

 

SPOT GRADE™ SCALE HEMOBLAST™ BELLOWS1 Effective hemostasis on SPOT GRADE™ levels 1 through 3: minimal, mild, and moderate bleeding in light of approved indications.1
SPOT GRADE™ 0 1 2 3 4 5
Maximum Expected
ACS-ATLS*
Shock Risk Class
1 1 1 2 3 4
Verbal Descriptor None Minimal Mild Moderate Severe; not immediately
Life-threatening
Extreme; immediately
Life-threatening
Visual Descriptor Dry Oozing Pooling Flowing Streaming Gushing
Expected
Intervention(s)
None Manual pressure, cautery, adjuvant hemostat(s) Manual pressure, cautery, suture, adjuvant hemostat(s) Manual pressure, cautery, suture, adjuvant hemostat(s) Manual pressure, cautery, suture, staples, tissue repair Manual pressure, cautery, suture, staples, 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 (cm2) 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™ Bellows against absorbable gelatin sponge and thrombin involved 242 patients randomized across 16 sites and found HEMOBLAST™ Bellows statistically superior at achieving hemostasis:

  • 71.1% vs. 45.8% at 3 minutes (p=0.001)1
  • 93.1% vs. 73.5% at 6 minutes (p=0.001)1
  • No clinical signs or symptoms of postoperative bleeding with HEMOBLAST™ Bellows1

*American College of Surgeons – Advanced Trauma Life Support.

1. HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Biom’up SA. 13. Evarrest Fibrin Sealant Patch [prescribing information]. Somerville, NJ; Ethicon Inc. 16. Spotnitz WD, Zielske D, Centis V et al. The SPOT GRADE: a new method for reproducibly quantifying surgical wound bleeding. Spine (Phila Pa 1976). 2017 Oct 10. doi: 10.1097/BRS.0000000000002447. [Epub ahead of print]

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 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. The presentation contains pictures owned by third party and remains their property.
E-MR-318-V1
HEMOBLAST™ Bellows Hemostatic Agent [instructions for use: E-MR-217-V6]