Clinical studies TRL 6 Hemostasis

Hemostatic Fibril & Brain Pad

A specialised absorbable hemostat for neurosurgery — removing the need for a second operation to retrieve the hemostat from the skull.

Key features

  • Fully absorbed by the body
  • No second operation required
  • Designed for neurosurgery
Technical overview

About Hemostatic Fibril & Brain Pad

Healda's hemostatic fibrils and brain pads are an advanced generation of hemostatic agents based on oxidised regenerated cellulose (ORC), developed specifically for bleeding management in neurosurgery and other delicate tissue. Their fibrillar, layered structure creates a large contact surface with blood platelets and lowers the local pH, accelerating natural clot formation. The soft, pliable fibrils let the surgeon place the material easily into irregular surgical cavities and achieve hemostasis without damaging brain parenchyma.

Manufacturing takes place at Healda using modern biopolymer separation and purification technology. Thanks to their high biocompatibility, the pads need not be removed at the end of the procedure: they are absorbed completely through an enzymatic process without causing adhesions or secondary immune reactions. Beyond hemostasis, the acidic environment the fibrils create is bacteriostatic against a broad spectrum of bacterial pathogens, reducing the risk of post-operative infection in sensitive neurological procedures.

Datasheet

Technical specifications

Base material
High-purity oxidised regenerated cellulose (ORC)
Biological absorption time
7 to 14 days (depending on tissue type)
Sterilisation method
Gamma irradiation
Physical structure
Layered, easily peelable fibrils
Storage conditions
15–30 °C, away from direct moisture
Final packaging
Double-walled medical pouch with a sterilisation indicator
Clinical applications

Applications

Brain tumour surgery

Control of capillary and venous bleeding at the cortex and in brain parenchyma.

Cerebrovascular surgery

Hemostasis in hard-to-reach sites and control of vascular leakage in aneurysm repair.

Spinal and spinal-cord surgery

Used as a protective hemostatic layer in laminectomy and discectomy.

Epidural and subdural bleeding

Prevention of bleeding from the dural sinuses after opening the skull.

Skull base surgery

Prevention of secondary adhesions and control of bleeding in sensitive cranial regions.

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 In progress
ISO 10993 Biocompatibility evaluation In progress
Pre-clinical studies Animal studies in progress In progress
IRC Iranian Ministry of Health marketing authorisation Planned
FAQ

Common questions about this product

How long does this hemostat take to be fully absorbed?
The product is fully absorbed into body tissue within 4 to 7 days and leaves no lasting inflammatory reaction.
Does the fibril stick to surgical instruments if it needs repositioning?
No. Thanks to their distinctive fibrillar structure, the pads can be lifted easily with forceps or other instruments and do not stick to gloves or tools.
Does the product contain any animal-derived material?
No. It is produced from a plant source (pure cotton) and contains no animal components or human proteins.
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