Biostealth technology for conventionally cross-linked biologic medical devices
Facta® is a biostealth technology designed to counteract degenerative processes in the biological tissues used to manufacture medical devices that have been previously subjected to fixation and sterilization with agents such as aldehydes and epoxydic resins.
While maintaining full device functionality, Facta is engineered to inhibit common reasons for device failures, such as immune rejection and inflammatory reactions, thrombosis, infection, and calcification.
Medical devices treated with Facta technology promise to deliver superior clinical performance.
Facta harnesses a patented formulation of plant-based ingredients
Applications
Cardiovascular
- Percutaneous valves
- Surgical valves
- Biologic tissue patches
Orthopedics
- Tendons and ligaments
- Bones
- Biomaterials (matrices, fibers)
Endovascular applications
- Vascular patches
- Dialysis fistulae
- Others
Women’s health
- Vaginal reconstruction
- Breast reconstruction
Neurology
- Intervertebral discs
- Dura mater
- Bioartificial nerves
- Others
Benefits of Facta
Facta is designed to increase the biocompatibility and durability of medical devices, rendering these devices highly resistant to physiologic reactions and extending their lifespan.
- Almost complete inhibition of immune system response
- 99% reduction in calcium deposition
- 96% reduction of infection incidence due to lower bacterial adhesiveness
- 90% fewer blood clots
- No leaching or delamination from devices, no chemical degradation, and no toxic effects for patients
- Detoxification from aldehydic, epoxy, and other industrial chemical proprietary treatment residues
- Improved biomechanical properties
How Facta Works
Facta creates a permanent bridge between biological tissue and aldehyde-based fixatives, forming a protective 3D network stabilizing the biomaterial and stopping tissue degeneration.
By permanently capping free aldehyde groups, Facta dramatically reduces the risk of calcification.
Protection against the chief reasons for device failure and limited duration
Facta’s Key Advantages
1.
Prevents circulating antibodies from binding to antigens located both on the tissue surface and within the underlying matrix
2.
Strongly mitigates pathogenic microorganisms from binding and colonizing the substrate
3.
Avoids the precipitation of calcium and the activation of the coagulation cascade, countering the formation of blood clots