δRapid action demonstrated in 3 RCTs showing superiority of achieving Time To Haemostasis compared to Surgicel™. Durability is demonstrated in 3 RCTs by the ability of forming and maintaining the clot for the 10min period of the studies. Adherence was demonstrated in bench top tests on animal models.

*Reliable based on reproducible clot formation compared to control. Nenezic: Ratio of patient proportion meeting primary end point is 95% (P<0.001). Bjelovic: Rate of Hemostasis after 4 min is 92.4%

¥In 3 RCTs, haemostasis was achieved between 2-10 minutes and was sustained for the 10 min observational period (90.2% for Veraseal™ vs 69.8% for control)

≠Based on number of set-up steps and thawing time required for VERASEAL™ Dual Applicator vs competitors (Tisseel™ and Evicel™)

±Comparing 10ml thawing time for VERASEAL™ Dual Applicator vs competitors (Tisseel™ and Evicel™)

≥VERASEAL 10ml (5 minutes) vs TISSEEL 10ml Prima Syringe (10 minutes)

πThe in-vitro study purpose was to assess and compare the Spray Coverage Area and angled adherence of the VERASEAL™ Fibrin Sealant Dual Applicator device to the TISSEEL™ spray set. It showed that VERASEAL™ with the Airless Spray Accessory is capable of better spray control and targeting of the fibrin sealant at 2 cm (P ≤0.0001) while results are not significantly different at 5cm.

^For safety reasons, all gas assisted devices should be sprayed at least 10cm away from the target tissue (as per their IFUs)

µThe In-Vitro study purpose was to assess and compare the Spray Coverage Area and angled adherence of the VERASEAL™ Fibrin Sealant Dual Applicator device to the TISSEEL™ spray set on plastic sheets. It showed that VERASEAL™ with the Airless Spray Accessory is capable of better spray control and targeting of the fibrin sealant at 2 cm (P ≤0.0001) while results are not significantly different at 5cm

**1mL of each of the fibrin sealants was shown to cover a 10cm2 area

δVeraseal™ Dual Applicator provide more precise spraying control as it allows use 2cm away from tissue compared to Tisseel™ and Evicel™ gas assisted spraying which should be at least 10cm away from tissue as recommended in their SmPC

1. Bjelovic M, Ayguasonosa J, Kim RD, et al. A prospective, randomized, phase III study to evaluate the efficacy and safety of fibrin sealant Grifols as an adjunct to hemostasis as compared to cellulose sheets in hepatic surgery resections, J Gastrointest Surg:2018: 22:1939–1949 (137144-200416, 137157-200416)

2. Nenezic, A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery, J of Vasc Surg, 2019;70;1642 (137144-200416, 137157-200416)

3. Ethicon, 100652447, Completion report for Instron testing of tissue adhesion strength of Vistaseal™, Evicel™ and Tisseel™, Sept 2018, Data on File (137144-200416)

4. Lakshman, A Prospective, Single-Blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Soft Tissue Open Surgery, J Invest Surg;2020;218;33 (137144-200416)

5. Chetter I, Stansby G, Sarralde JA, et al. A prospective, randomized, multicenter clinical trial on the safety and efficacy of a ready-to-use fibrin sealant as an adjunct to hemostasis during vascular surgery. Ann Vasc Surg:2017;45127–137 (137143-200416)

6. Bjelovic M, Ayguasonosa J, Kim RD, et al. A prospective, randomized, phase III study to evaluate the efficacy and safety of fibrin sealant Grifols as an adjunct to hemostasis as compared to cellulose sheets in hepatic surgery resections. J Gastrointest Surg;2018: 221939–1949 (137143-200416)

7. Hunt BJ. Bleeding and coagulapathies in critical care, N Engl J Med:2014:370:847-859 (137143-200416)

8. Nenezic et al, A prospective, single-blind, randomized, phase III study to evaluate the safety and efficacy of Fibrin Sealant Grifols as an adjunct to hemostasis compared with manual compression in vascular surgery, Journal of Vascular Surgery;2019;1-10 (137143-200416)

9. Lakshman, A Prospective, Single-Blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols as an Adjunct to Hemostasis During Soft Tissue Open Surgery, Journal of Investigative Surgery:0:1–13, 2018 (137143-200416)

10. Ethicon, 100708726, Thawing time and set-up steps comparison between VISTASEAL™, EVICEL™ and TISSEEL™, Aug 2019, Data on File (137502-200420)

11. TISSEEL™ Summary of Product Characteristics (137502-200420, 150335-200818, 137508-200420 )

12. VERASEAL™ Summary of Product Characteristics (137502-200420, 150335-200818, 137508-200420 )

13. EVICEL™ Summary of Product Characteristics (137502-200420)

14. Ethicon, 100682576 Completion report for Angled Adherence Adaptiv, Dec 2018, Data on File (137508-200420)

15. Ethicon, 100682576, Completion Report for Angled Adherence, December 2018, Data on File (137148-200416)

16. Ethicon, PSB004796, Evaluation of the hemostatic efficacy of Grifols fibrin sealant (human) delivered by VistaSeal open delivery system using an acute swine model, October 2018, Data on File (137148-200416)

17. Completion report for manual spray coverage area. 100682978. December 18, 2018. Ethicon, Inc (137488-200420)

18. Ethicon, 100682576, Completion Report for Angled Adherence, December 2018, Data on File  (137146-200910)

19. Ethicon, 100675646 Rev 1, Phillips R. VISTASEAL ASA Design Verification Memo for Expression Force and Surface Area, December 2018, Data on File (137146-200910)

 

191004-210929