Thrombosis Assay

The thrombus is a mixture composed of red cells, aggregated platelets, fibrin and other cellular elements, which can cause partial or complete occlusion of a vessel.

STEMart provides thrombosis assay to help manufacturer demonstrate the regulatory compliance of product to blood/device interaction.

Standard of Thrombosis Assay

ISO 10993-4

FDA requirement

STEMart provides thrombosis assay for the medical device including but limited to:

• External communicating devices in contact with circulating blood
• Blood monitors
• Extracorporeal membrane oxygenator system
• Hemodialysis/hemofiltration equipment
• Percutaneous circulatory support devices
• Catheters
• Guidewires
• Intravascular endoscopes
• Intravascular ultrasound
• Laser systems
• Retrograde coronary perfusion catheters
• Implant devices placed largely or entirely within the vascular system
• Annuloplasty rings
• Mechanical heart valves
• Total artificial hearts
• Ventricular-assist devices
• Endovascular grafts
• Implantable defibrillators and cardioverters
• Pacemaker leads
• Stents
• Tissue heart valves
• Tissue vascular grafts and patches
• Prosthetic (synthetic) vascular grafts and patches
• Vena cava filters
• Intra-aortic balloon pumps

Test Principle of Thrombosis Assay

• Percentage occlusion
• Flow reduction
• Gravimetric analysis
• Light microscopy
• Pressure drop across device
• Scanning electron microscopy
• Antibody binding
• Retrieval and examination of device
• Autopsy of distal organs
• Imaging techniques

If you have additional questions about Thrombosis Assay or would like to find out more about our services, please feel free to contact us.

Reference

• International Organization for Standardization. Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood. ISO 10993-4; (2002).