Acute Particulate Matter Evaluation: Measured parameters
- Total cumulative number of particulate matter released from the device during
Unconstrained device deployment
Simulated use conditions
Background noise assessment
- 75% and 90 % Spiking and recovery study
- Surface defects and coating integrity inspection
Acute Particulate Matter Evaluation: Scope
- Acute Particulate Matter Evaluation: Any coated interventional devices
- Acute Particulate Matter Evaluation: PTA, PTCA catheters
- Acute Particulate Matter Evaluation: Coronary and peripheral stent: DES or coated
Acute Particulate Matter Evaluation: Applicable standards
- ISO 25539-2 – CARDIOVASCULAR IMPLANTS – ENDOVASCULAR DEVICES – PART 2: VASCULAR STENTS
- ASTM F2743 – 11 STANDARD GUIDE FOR COATING INSPECTION AND ACUTE PARTICULATE CHARACTERIZATION OF COATED DRUG-ELUTING VASCULAR STENT SYSTEMS
- FDA GUIDELINES – GUIDANCE FOR INDUSTRY AND FDA STAFF NON-CLINICAL ENGINEERING TESTS AND RECOMMENDED LABELING FOR INTRAVASCULAR STENTS AND ASSOCIATED DELIVERY SYSTEMS
- GLP STUDIES PER CODE OF FEDERAL REGULATIONS CFR21, PART 58 – GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
Acute Particulate Matter Evaluation: Associated tests
- Device pre-conditioning – Simulated use on IDTE 2000
- Optical Inspection
- Scanning Electron Microscopy (SEM)
- Coating integrity
Acute Particulate Matter Evaluation: Test method description
Particulate matter can be generated from degradation or delamination of coated devices such as stent delivery systems, drug-eluting stents and hydrophilic coated catheters. Introduction of particulate matter in the blood stream during acute clinical use may present an embolic risk to the patient. In order to evaluate the amount of particulate matter generated from coated medical devices, PROTOMED and MACHINE SOLUTIONS INC. have jointly developed A NEW TEST METHOD based on the ASTM F2743 test standard recommendations, combining state of the art equipment for interventional device testing and device testing expertise. This new test provides an accurate method to measure the quantity and the size of particulate matter that devices can generate. Our NEW CONTINUOUS FLOW IN-LINE PARTICULATE MATTER measurement test method uses the following technology:
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Our IN-LINE multi channel continuous flow particulate counting system is used to automatically measure and display real time particulate contamination levels in the circulating solution during testing. Particles are continuously monitored, counted and classified according to customizable size ranges.
The Interventional Device Testing Equipment (IDTE) 2000 is used to comparatively and quantitatively record TRACK and TORQUE performance parameters of interventional devices including stent, catheters, guidewires and percutaneous heart valves delivery systems, colonoscopes, endoscopes and many other interventional devices. The IDTE equipment is PC controlled with numerous options for TRACK/TORQUE configuration and allows 2D and 3D anatomical track testing.
A Scanning Electron Microscope (SEM) and/or an optical microscope with proper magnification is used to inspect the surface defects and coating integrity of the device before and after testing. Coating anomalies, defects or artefacts are located and documented.
A Spectroscopic Analysis is used to identify the chemical composition of particulate material to differentiate coating and delivery system particulates from those from other sources.