Market ready TRL 8-9 Hemostasis

AriClot™ Hemostatic Gelfoam

Absorbable AriClot hemostatic sponge that stops bleeding fast and provides a three-dimensional scaffold for tissue regeneration in surgery and dentistry.

Key features

  • Porous structure with controlled porosity
  • Biocompatibility in line with ISO 10993
  • Used in general surgery and dentistry
  • No removal required after healing
Technical overview

About AriClot™ Hemostatic Gelfoam

AriClot Hemostatic Gelfoam is a flexible, biodegradable surgical sponge produced by the knowledge-based company Healda from pure pharmaceutical-grade gelatin. Its irregular porous structure forms a physical and mechanical barrier at the bleeding site and provides an ideal matrix for platelet aggregation and activation of clotting factors. On contact with blood the micron-scale pores fill, accelerating fibrin clot formation and delivering strong control of capillary and venous bleeding even in patients on anticoagulant therapy.

Clinically, AriClot acts not only as a hemostat but also as a temporary scaffold for cell migration and tissue regeneration. It is fully biocompatible and provokes no inflammatory or immune reaction; complete absorption in soft tissue takes between 2 and 4 weeks depending on the site. Because the gelfoam is flexible and can be cut to shape, the surgeon can place it easily in cavities and hard-to-reach spaces. Once saturated with blood, the sponge conforms to irregular wound surfaces and prevents re-bleeding.

Datasheet

Technical specifications

Base material
High-purity pharmaceutical-grade gelatin
Physical structure
Porous sponge absorbing up to 40× its weight in fluid
Sterilisation method
Gamma irradiation
Biological absorption time
2 to 4 weeks (depending on the target tissue)
Packaging
Double sterile blister, 80 × 50 × 10 mm
Storage conditions
Room temperature (15–30 °C), away from direct moisture
Clinical applications

Applications

Dental and maxillofacial surgery

Control of bleeding in tooth-extraction sockets and maxillofacial procedures.

General and internal surgery

Sealing blood leakage in pelvic and abdominal surgery and in biopsies of internal organs.

Neurosurgery and orthopaedics

Used as a bulking agent and hemostat in laminectomy and spinal surgery.

Ear, nose and throat (ENT)

Absorbing secretions and controlling bleeding after rhinoplasty and sinus surgery.

Urological surgery

Used in urology, particularly after bladder tumour resection or prostate surgery.

Compliance

Certification and standards status

The status of national and international certifications for this product.

Certification Description Status
ISO 13485:2016 Quality management system for medical devices Obtained
ISO 10993 Biocompatibility evaluation Obtained
IRC Iranian Ministry of Health marketing authorisation In progress
FAQ

Common questions about this product

Does the AriClot sponge need to be removed after surgery?
No. The product is biologically inert and, once healing is complete, is fully broken down and absorbed by the body's enzymes.
Can the gelfoam be re-sterilised?
No. The product is supplied sterile and must not be re-sterilised; re-sterilisation destroys the porous gelatin structure.
How much blood can the product absorb?
AriClot can absorb up to 40× its own weight in blood and exudate, driving rapid platelet aggregation.
Can AriClot be used for severe arterial bleeding?
No. The product is designed for venous and capillary bleeding and must not be used to control high-pressure arterial bleeding.
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Hemostasis Details