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)), 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 metallic frame or support structure testing services 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.
For catheter based delivery systems see additional tests here.
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 test sample and a user-defined standard with or without the use of a body mimic.Learn more