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.

Courtesy of Occlutech International AB

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Acute Particulate Matter Evaluation

An in-line continuous particulate counting system is used to assess the number and sizes of  particles generated during simulated use in real-time inside an anatomical model.

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Corrosion Galvanic

Evaluation of corrosion of device with different type of metals.

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Corrosion Potentiodynamic

Corrosion susceptibility of small, metallic, implant medical devices, or components thereof, using cyclic (forward and reverse) potentiodynamic polarization.

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Dimensional Attributes

A contactless optical gauging machine is used to measure dimensional attributes of the device.

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Smartscope
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Engineering Support

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.

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Literature Review

ViVitro can perform a literature review to support the development of a specific device.  This can used to build a rational as requested by the client.

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Radial Fatigue and Pulsatile Durability

Determine the fatigue resistance of a stent using an in-vitro accelerated test.

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Radiopacity

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.

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Scanning Electron Microscopy (SEM) and Optical Inspection

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Simulated Use Testing Under Pulsatile Flow

Devices can be subjected to various physiological pulsatile flows and pressures.

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