Drug Database
AV

Avitene (Avitene)

✓ Approved

Zeria · therapeutic agent

What is Avitene?

Avitene is a therapeutic agent developed by Zeria. It is approved for therapeutic indications.

Drug Profile

Brand NamesAvitene
CompanyZeria
StatusApproved
Sources: ClinicalTrials.gov, Zeria

Therapeutic Indications

Avitene is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Vascular disordersExtravasation blood✓ Approved
Vascular disordersHaemorrhage✓ Approved

Related Research Articles

PubMedHPB : the official journal of the International Hepato Pancreato Biliary Association2026-05-18

Microfibrillar collagen hemostat (Avitene™) can mimic peritoneal metastases after primary percutaneous bile duct stenting for malignant hilar obstruction.

van Verschuer Victorien M T VMT, Luyten Julien A JA, Holster Jessica J, Rousian Merve M et al.

Primary Percutaneous Stenting (PPS) is a novel drainage technique for malignant hilar biliary obstruction (MHBO), typically caused by perihilar cholangiocarcinoma. During PPS, the percutaneous tract is sealed with Avitene™ Microfibrillar Collagen Hemostat (MCH) to avoid an external drain. This report describes the radiological, intraoperative, and histopathological appearance of MCH following PPS in resectable MHBO. We reviewed all patients with MHBO who underwent PPS and surgical exploration at two Dutch academic hospitals between 2022-2025. Macroscopic findings were documented by the surgeon, and tissue from suspicious lesions was evaluated with frozen section and definitive histology to differentiate malignant lesions from reactive ones due to MCH deposits. Twenty-one patients underwent surgical exploration after PPS. In fourteen patients, white-yellow capsular lesions were identified at the PPS puncture site that were macroscopically suspicious for peritoneal metastases. Histology revealed foreign body reactions with eosinophils, giant cells, amorphous material, and focal necrosis. No malignant cells were identified. Two patients had peritoneal metastases, yet the lesions along the PPS tract were negative for malignancy. MCH deposits along the PPS puncture tract can resemble PM during surgical exploration. Recognizing this characteristic appearance is important to prevent misinterpretation and alter surgical decision making.

PMID 42144305
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PubMedCVIR endovascular2025-12-09

Transhepatic access closure for islet cell transplant in anticoagulated patients: a comparison of microfibrillar collagen paste, coils, and coil plus gel foam.

Yu Qian Q, Tran Patrick P, Ungchusri Ethan E, Karani Kunal K et al.

To evaluate the safety and effectiveness of microfibrillar collagen paste (MCP), coils, and coils combined with gelatin sponge for transhepatic access tract embolization following portal vein islet cell transplant. A retrospective review was conducted at a single institution between January 2008 and October 2024, including 20, 28, and 21 consecutive islet cell transplant procedures requiring transhepatic access embolization with MCP, coils, and coil plus gelatin sponge, respectively. All procedures were performed via a right portal vein branch. MCP was performed using Avitene (BD). The average number of coils required in the coil plus gelatin sponge and coil-only groups were 1.8 and 1.6 coils per procedure, respectively. All patients were placed on therapeutic anticoagulation during the procedure and for at least two weeks post-transplant. Medical records were reviewed to compare laboratory results, portal venous pressures, post-procedure liver ultrasounds, and 30-day hemorrhagic events across the three groups. All procedures were technically successful. However, one instance of coil migration into a portal vein branch occurred in the coil plus gelatin sponge group (1/28, 3.5%). Baseline hemoglobin, platelet counts, and partial thromboplastin time did not differ significantly between groups (p > 0.05). A statistically significant lower international normalized ratio (INR) was observed in the MCP group compared to the gelatin sponge and coil-only groups (1.0 vs. 1.1 vs. 1.1, p = 0.0036 and 0.004). No statistically significant differences were found in hemoglobin changes, post-transplant portal venous pressures, or post-embolization hemorrhagic events (p > 0.05). One patient in the coil plus gelatin sponge group developed a large subcapsular hematoma (1/27, 3.7%), while another in the MCP group experienced a large right hemothorax (1/20, 5.0%). MCP, coils, and coil plus gelatin sponge are similarly effective for transhepatic access closure following islet cell transplant in anticoagulated patients. However, coil embolization may require multiple coils and carries a risk of migration.

PMID 41364309
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PubMedAdvanced healthcare materials2025-09-03

Absorbable Adhesive Composite Hemostatic Sponge Based on Decellularized Extracellular Matrix and Mussel Adhesive Protein for Internal Bleeding Control.

Cha Hyegyo H, Lee Jaeyun J, Kang Dayoon D, Kim Daekeun D et al.

Hemostatic biomaterials for internal applications require strong wet adhesion, reasonable degradability, and supportive biocompatibility for wound healing. However, clinically used topical hemostats such as Surgicel and Avitene may induce hemolysis, inflammation, or leave behind residual debris that impairs healing. Bioinspired materials, including decellularized extracellular matrix (dECM) and mussel adhesive protein (MAP), have emerged as promising alternatives for their hemostatic potential and biocompatibility. Based on the biomimetic properties of dECM and the adhesive functionality of MAP, composite sponges combining both components are developed and evaluated through in vitro and in vivo tests. Among the formulations tested, E50M50 (9.1% w/w dECM and 90.9% w/w MAP) demonstrates the strongest hemostatic performance. This synergy is identified to be primarily associated with the secondary hemostasis phase. E50M50 also exhibits excellent hemocompatibility, cytocompatibility, and a reasonable biodegradability aligned with early wound healing phases. In a warfarin-treated rat liver injury model, E50M50 significantly reduces bleeding time and blood loss compared to clinical controls. Histological analysis further confirms that E50M50 provided superior early healing outcomes than Avitene, with significantly reduced necrosis, fibrosis, and residual debris. These results highlight the potential of ECM-MAP sponges as absorbable, adhesive hemostats for internal bleeding control and early-stage wound stabilization.

PMID 40899565
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PubMedSpine surgery and related research2025-04-14

Development and Evaluation of Thrombin-Loaded Gelatin Hemostatic Sheets for Spinal Surgery Applications.

Kawabata Atsuyuki A, Egawa Satoru S, Ogino Makoto M, Yoshii Toshitaka T

During spinal surgery, management of intraoperative bleeding and effective hemostasis are required to clearly visualize the surgical field and to safely perform procedures and positive postoperative outcomes. However, it is challenging to stop bleeding from the venous plexus around the dural sac due to the potential risk of neural tissue damage. We aimed to develop hemostatic sheets with appropriate characteristics for spinal surgery, such as softness, appropriate thickness, biodegradability, thrombin bioactivity, and minimal water-induced expansion. Hemostatic sheets were made by dissolving bovine bone-derived gelatin in water and aerating it to form foam, followed by freeze-drying, crosslinking, and thrombin-soaking. Sheets A to H were produced with different gelatin concentrations, foam densities, and crosslinking times by additional heat treatment. The sheets were then soaked in thrombin solution for enhanced hemostasis. Material properties, such as density, tensile strength, biodegradability, and hemostatic capacity, were evaluated. Sheet efficacy was further assessed with liver bleeding and spinal venous plexus bleeding models in a miniature pig. High-density gelatin sheets showed stable shape retention in wet conditions and robust tensile strength. Sheets with higher density and more crosslinking had prolonged persistence in the pepsin test and lower biodegradability in vivo. Sheet B, produced from a 4% gelatin solution with heating at 155°C for 4 h, showed the best balance of properties, such as no deformation cracks, rapid water absorption, minimal expansion, and faster degradation within 10 weeks, compared with TachoSil and other sheets. In hemostasis models, Sheet B outperformed Avitene and TachoSil, achieving higher success rates in spinal (four out of six sites) and liver bleeding (five out of five sites) models. A thrombin-loaded hemostatic sheet produced from 4% gelatin solution with a short heating time for crosslinking demonstrated well-balanced material properties, such as shape retention, biodegradability, and wet expansion rate, which resulted in effective hemostasis in in vivo models. These advances may contribute to surgical hemostatic applications.

PMID 40223830
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PubMedJournal of materials chemistry. B2025-01-06

Bottom-up reconstitution design of a biomimetic atelocollagen microfibril for enhancing hemostatic, antibacterial, and biodegradable benefits.

Zhang Xiaoxia X, Cai Lin L, Li Guoying G

Powdered collagen is emerging as a promising topical hemostat owing to its adaptability to various wounds, active hemostatic abilities, and biosafety. The reproduction of a bionic structure similar to natural collagen is crucial for effective hemostasis and bioactivity. Additional factors relevant to clinical application include antimicrobial properties, minimal immune response, and straightforward preparation. However, current developments in collagen hemostatic powders often lack comprehensive integration of these multidimensional attributes. In this study, atelocollagen molecules and antimicrobial peptide (ε-polylysine) were successfully employed to achieve the simultaneous expression of biomimetic structures and antimicrobial functions through a bottom-up reconstruction design. The synergistic effects of low temperature and mechanical processing facilitated the dispersion of collagen fibrils without leading to a stiffened network. The resultant atelocollagen microfibril (BCF-10) exhibited biomimetic D-periodicity and a fluffy morphology. BCF-10 demonstrated excellent antimicrobial properties and biocompatibility. Notably, BCF-10 could absorb blood up to 12 times its own weight within 15 s and significantly activate platelets to promote coagulation. In both a rat tail amputation model and a liver multi-point puncture model, BCF-10 exhibited significantly improved hemostatic capability compared to commercially available gauze (****P < 0.0001) and was found to be comparable to the well-established microfibrillar collagen hemostat, Avitene. Immune response assessments indicated that BCF-10 could be biodegraded within 30 days without eliciting a severe inflammatory response, and could serve as a scaffold for cellular infiltration to promote tissue regeneration. This research presents a straightforward and effective strategy for preparing a biomimetic atelocollagen microfibril that is efficient in hemostasis, infection prevention, and rapid biodegradability, positioning BCF-10 as a promising candidate for clinical translation and application.

PMID 39760512
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PubMedBiomaterials science2023-07-17

Electron beam irradiation modified carboxymethyl chitin microsphere-based hemostatic materials with strong blood cell adsorption for hemorrhage control.

Leng Fan F, Li Taotao T, Li Tongfei T, Xie Cong C et al.

Timely control of coagulopathy bleeding can effectively reduce the probability of wound infection and mortality. However, it is still a challenge for microsphere hemostatic agents to achieve timely control of coagulopathy bleeding. In this work, the CCM-g-AA@DA hemostatic agent based on carboxymethyl chitin microspheres, CCM, was synthesized using electron beam irradiation-induced grafting polymerization of acrylic acid and coupling with dopamine. Irradiation grafting endowed the microspheres with excellent adsorption performance and a rough surface. The microspheres showed a strong affinity to blood cells, especially red blood cells. The maximum adsorption of red blood cells is up to approximately 100 times that of the original microspheres, the CCM. The introduction of dopamine increased the tissue adhesion of the microspheres. At the same time, the microspheres still possessed good blood compatibility and biodegradability. Furthermore, the CCM-g-AA@DA with Fe3+ achieved powerful procoagulant effects in the rat anticoagulant bleeding model. The bleeding time and blood loss were both reduced by about 90% compared with the blank group, which was superior to that of the commercially available collagen hemostatic agent Avitene™. In summary, the CCM-g-AA@DA hemostatic agent shows promising potential for bleeding control in individuals with coagulation disorders.

PMID 37458611
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