Last update 21 Jun 2024
Fibrin Sealant (Human)(Instituto Grifols)
Last update 21 Jun 2024
Overview
Basic Info
Drug Type Non-recombinant coagulation factor |
Synonyms FS Grifols, Human Fibrinogen/Human Thrombin, Human fibrinogen/human thrombin - Grifols + [2] |
Target |
Mechanism fibrin modulators(Fibrin modulators) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (01 Nov 2017), |
Regulation- |
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Related
8
Clinical Trials associated with Fibrin Sealant (Human)(Instituto Grifols)A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.
A Prospective, Randomized, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis During Surgery in Paediatric Subjects
A Prospective, Randomised, Active-Controlled, Single-blind, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Fibrin Sealant Grifols (FS Grifols) as an Adjunct to Haemostasis during Surgery in Paediatric Subjects.
100 Clinical Results associated with Fibrin Sealant (Human)(Instituto Grifols)
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100 Translational Medicine associated with Fibrin Sealant (Human)(Instituto Grifols)
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100 Patents (Medical) associated with Fibrin Sealant (Human)(Instituto Grifols)
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38
Literatures (Medical) associated with Fibrin Sealant (Human)(Instituto Grifols)01 Apr 2023Journal of biomedical materials research. Part A
A comparative high‐resolution physicochemical analysis of commercially available fibrin sealants: Impact of sealant osmolality on biological performance
Article
Author: Heher, Philipp ; Singh, Rahul ; Slezak, Paul ; Manhartseder, Stefan ; Reichsöllner, Raffael ; Hartmann, Jaana ; Gulle, Heinz
Abstract:
Fibrin sealants are well‐established components of the surgical toolbox, especially in procedures that harbor a high risk of perioperative bleeding. Their widespread use as hemostats, sealants or tissue‐adhesives in various surgical settings has shown that the choice of the appropriate sealant system affects the clinical outcome. While many studies have compared the hemostatic efficiency of fibrin sealants to that of other natural or synthetic sealants, there is still limited data on how subtle differences in fibrin sealant formulations relate to their biological performance. Here, we performed an in‐depth physicochemical and biological characterization of the two most commonly used fibrin sealants in the US and Europe: TISSEEL™ (“FS”) and VISTASEAL™/VERASEAL™ (“FS+Osm”). Our chemical analyses demonstrated differences between the two sealants, with lower fibrinogen concentrations and supraphysiological osmolality in the FS+Osm formulation. Rheological testing revealed FS clots have greater clot stiffness, which strongly correlated with network density. Ultrastructural analysis by scanning electron microscopy revealed differences between FS and FS+Osm fibrin networks, the latter characterized by a largely amorphous hydrogel structure in contrast to the physiological fibrillar network of FS. Cytocompatibility experiments with human fibroblasts seeded on FS and FS+Osm fibrin networks, or cultured in presence of sealant extracts, revealed that FS+Osm induced apoptosis, which was not observed with FS. Although differential sealant osmolality and amounts of fibrinogen, as well as the presence of Factor XIII or additives such as antifibrinolytics, may explain the mechanical and structural differences observed between the two fibrin sealants, none of these substances are known to cause apoptosis at the respective concentrations in the sealant formulation. We thus conclude that hyper osmolality in the FS+Osm formulation is the primary trigger of apoptosis—a mechanism that should be evaluated in more detail, as it may affect the cellular wound healing response in situ.
01 Jun 2024Cartilage
Mechanical Evaluation of Commercially Available Fibrin Sealants for Cartilage Repair.
Article
Author: Athanasiou, Kyriacos A ; Amirhekmat, Arya ; Brown, Wendy E ; Hu, Jerry C ; Wang, Dean ; Salinas, Evelia Y
OBJECTIVE:
Fibrin sealants are routinely used for intra-articular surgical fixation of cartilage fragments and implants. However, the mechanical properties of fibrin sealants in the context of cartilage repair are unknown. The purpose of this study was to characterize the adhesive and frictional properties of fibrin sealants using an ex vivo model.
DESIGN:
Native bovine cartilage-bone composites were assembled with a single application of Tisseel or Vistaseal. Composites were tested in tension and lap shear. In addition, the coefficient of friction (COF) was measured in a native cartilage annulus model alone and with minced cartilage. Finally, the effect of a double application of fibrin sealant was evaluated.
RESULTS:
There were no significant differences in tensile modulus, ultimate tensile strength (UTS), shear modulus, or ultimate shear strength (USS) between the 2 fibrin sealants. Both fibrin sealants demonstrated a UTS and USS of <8 and <30 kPa, respectively. There were no differences in COF between the sealants when tested alone or with minced cartilage. A double application of fibrin sealant did not alter the mechanical properties compared with a single application of fibrin sealant.
CONCLUSIONS:
Fibrin sealant adhesive properties are not affected by the sealant type studied or the number of applications in a bovine cartilage-bone model. Fibrin sealant tribological properties are not affected by sealant type or the addition of minced cartilage. The adhesive properties of Tisseel and Vistaseal were less than those desired for the in vivo fixation of cartilage repair implants. These findings motivate the development of an improved cartilage-specific adhesive for cartilage repair applications.
01 Jan 2021Annals of medicine and surgery (2012)
Comparison of fibrin sealants in peripheral vascular surgery: A systematic review and network meta-analysis
Review
Author: Garcia, David ; Danker Iii, Walter ; Ferko, Nicole ; DeAnglis, Ashley ; Hogan, Andrew
BACKGROUND:
Evidence comparing fibrin sealants (FSs) in surgery are limited. This study evaluated the efficacy and safety of FSs, and manual compression in peripheral vascular surgery.
METHODS:
A systematic review of randomized trials was conducted in Medline, Embase, and Cochrane databases within the last 15 years. Data were available to conduct a network meta-analysis (NMA) in peripheral vascular surgery. Fibrin sealant treatment arms were further broken-down and assessed by clotting time (i.e., 2-min [2C] or 1-min [1C]). The primary efficacy outcome was the proportion of patients achieving hemostasis by 4 min (T4). Treatment-related serious and non-serious adverse events (AEs) were qualitatively assessed.
RESULTS:
Five studies (n = 693), were included in the NMA. Results predicted VISTASEAL 2C, followed by EVICEL 1C, had the highest probability of achieving T4. Compared with manual compression, significant improvements in T4 were found with VISTASEAL 2C (relative risk [RR] = 2.67, 95% CrI: 2.13-3.34), EVICEL 1C (RR = 2.58, 95% CrI: 2.04-3.23), VISTASEAL 1C (RR = 2.00, 95% CrI: 1.45-2.65), and TISSEEL 2C (RR = 1.99, 95% CrI: 1.48-2.60). TISSEEL 1C was not significantly different than manual compression (RR = 1.40, 95% CrI: 0.70-2.33). Among FSs, VISTASEAL 2C was associated with a significant improvements in T4 compared with VISTASEAL 1C (RR = 1.33, 95% CrI: 1.02-1.82), TISSEEL 2C (RR = 1.34, 95% CrI: 1.05-1.77), and TISSEEL 1C (RR = 1.90, 95% CrI: 1.18-3.74). Treatment-related serious and non-serious AE rates were typically lower than 2%.
CONCLUSIONS:
In peripheral vascular surgeries, VISTASEAL 2C and EVICEL 1C were shown to have the highest probabilities for achieving rapid hemostasis among the treatments compared. Future studies should expand networks across surgery types as data become available.
33
News (Medical) associated with Fibrin Sealant (Human)(Instituto Grifols)28 Feb 2024
Phase 3AcquisitionClinical Result
20 Jul 2023
Clinical ResultImmunotherapyPhase 3Drug Approval
100 Deals associated with Fibrin Sealant (Human)(Instituto Grifols)
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R&D Status
10 top approved records. to view more data
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Blood Coagulation Disorders | EU | 10 Nov 2017 | |
| Blood Coagulation Disorders | IS | 10 Nov 2017 | |
| Blood Coagulation Disorders | LI | 10 Nov 2017 | |
| Blood Coagulation Disorders | NO | 10 Nov 2017 | |
| Hemorrhage | US | 01 Nov 2017 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 3 | 186 | (Fibrin Sealant Grifols) | wrgmgkjpsy(thsdcvokyw): Relative risk = 1 (95% CI, 0.92 - 1.09), P-Value = < 0.001; Relative risk = 1.03 (95% CI, 0.91 - 1.16), P-Value = < 0.001 View more | - | 07 Apr 2023 | ||
(EVICEL) | |||||||
Phase 3 | 225 | (Fibrin Sealant Grifols) | ppbrfqdgyk(jeyrcusbyh) = hnnglfemaj huaeccezpi (grdvpntaou, biygqmjqkv - ezbdxiljvd) View more | - | 06 Apr 2017 | ||
Manual Compression (Manual Compression) | ppbrfqdgyk(jeyrcusbyh) = eeroomaqfo huaeccezpi (grdvpntaou, yrsmefnxft - cqtcuhzrog) View more | ||||||
Phase 3 | 327 | (Fibrin Sealant (FS) Grifols) | awebjuqkxs(eaciubpmnd) = zhjsbmfusg wkzvjevonz (ppwrysvjja, ctirgmvhgt - ybjpxqcoga) View more | - | 23 Feb 2017 | ||
Surgicel® (Surgicel®) | awebjuqkxs(eaciubpmnd) = hifwowxqzz wkzvjevonz (ppwrysvjja, zjwhlgdvxs - bkhovdbwpu) View more | ||||||
Phase 3 | 325 | (Fibrin Sealant Grifols) | xqkkespbbj(bcutgsivuy) = bvvmbmunjw kzahuzemme (miptqcdygk, ygyeroffmt - iwbqcykcyk) View more | - | 08 Feb 2017 | ||
Surgicel® (Surgicel®) | xqkkespbbj(bcutgsivuy) = taevssencf kzahuzemme (miptqcdygk, kjatjykgdo - cjdruwmfwn) View more | ||||||
Phase 3 | 18 | ajllemgivk(dtxnbjpoqb) = ndvxrxsadz eknklzywzn (nmjqaaxcag, kkbrbbderz - boljjeluxr) View more | - | 08 Feb 2016 | |||
Phase 2/3 | 239 | (FS Grifols Primary Part (II)) | uyamirrflm(vqbbutszep) = tarpklifwl aswmomafyu (bsizjuwytk, luqqwxfkcy - yfjrxgnqlb) View more | - | 25 Jan 2016 | ||
Manual Compression (Manual Compression Primary Part (II)) | uyamirrflm(vqbbutszep) = actlnvaolf aswmomafyu (bsizjuwytk, laedhkkxyd - xxysjmnoxu) View more |
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