Metallic Frame Based Systems
With the rapid growth of the field of interventional cardiology many novel devices have been developed which employ metallic frames or support structures. These include shunts, occluders, Vena Cava filters, closure devices such (e.g. Left Atrial Appendage closure (LAA), and Atrial Septal Defects (ASD), ventricular septal defects (VSD) , patent foramen ovale (PFO), Patent ductus arteriosus (PDA), Paravalvular leakage devices (PVL), and many other cardiovascular devices. A number of methods are used to ensure these devices demonstrate safety, efficacy, and quality, while performing according to their intended use and labeling. We offer comprehensive occluder testing, closure device testing, and other metallic frame or support structure testing in accordance with ISO standards, ASTM Standards, FDA guidance documents, and the latest peer reviewed research.
ViVitro Labs is a leader in providing standardized as well as customized test methods for cutting edge or novel metallic frames or support structures such as occluder testing and closure device testing.
For catheter based delivery systems see additional tests here.
Accelerated Wear Testing (AWT)
Acute Particulate Matter Evaluation
ViVitro Labs can provide technical support and engineering solutions in the field of medical device testing. We provide flexible and responsive technical support services to help customers address project issues swiftly. Our clients can rapidly access engineers to discuss testing issues. Vivitro Labs provides a full range of engineering solutions through a true partnership with quality, integrity and confidentiality. These include customized test equipment solutions and customized test method development.Learn more
Radial Fatigue and Pulsatile Durability
Test specimens are exposed to X-Ray levels necessary for the imaging system and the product or material. Digital analysis method is used to produce the images in accordance with the equipment manufacturer’s instructions. Radiopacity of the device is determined by qualitatively comparing X-ray image(s) of a test sample and a user-defined standard with or without the use of a body mimic.Learn more
Scanning Electron Microscopy (SEM) and Optical Inspection
Simulated Use Testing Under Pulsatile Flow
ISO 22679 Cardiovascular implants — Transcatheter cardiac occluders
Standard is currently under development, but would cover all aspects of occluder testing and closure device testing. ViVitro Labs is an active contributor to ISO standards development.
ISO 25539-3:2011 Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters
Gives some guidance on how to test embolic protection devices
ASTM F2743-11(2018) Standard Guide For Coating Inspection And Acute Particulate Characterization Of Coated Drug-Eluting Vascular Stent Systems
Can be uses a reference for acute particulate matter evaluation for occluder testing, closure device testing, and other metallic frame or support structure testing
ASTM F2477 – 19 Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents
Used as a reference for durability testing for various device types
ViVitro has experience with a wide range of cardiovascular devices so our team of experts are well positioned to help with novel occluder testing, closure device testing, and other metallic frame or support structure testing. ViVitro products (and hence testing services) are highly versatile and have been used in many different applications to test a wide range of medical devices. Read more here how ViVitro has helped these cardiovascular pioneers achieve their goals.