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.

Occluder testing and closure device testing

Courtesy of Occlutech International AB

<

Accelerated Wear Testing (AWT)

Study the durability (repeated opening and closing) of a heart valve prosthesis under accelerated conditions.

Learn more
<

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.

Learn more
<

Corrosion Galvanic

Evaluation of corrosion of device with different type of metals.

Learn more
<

Corrosion Potentiodynamic

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

Learn more
<

Dimensional Attributes

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

Learn more
Smartscope
<

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.

Learn more
<

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.

Learn more
<

Radial Fatigue and Pulsatile Durability

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

Learn more
<

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 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

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

Learn more
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.

 

 

Join over 5000 cardiovascular device professionals who receive our testing and engineering insights and tips every month.