Circulatory Support Device Testing
Circulatory support devices may be required for heart failure patients as a bridge to transplant or destination therapy. These devices may be Ventricular Assist Devices (VAD, LVAD, RVAD) or total artificial hearts (TAH). Circulatory assistance may also be provided acutely for various reasons including additional flow requires during certain percutaneous procedures. These devices may include Inter-aortic balloon pumps (IABP) or Ventricular Support Systems. 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 circulatory support device 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 Circulatory support device testing and circulatory assistance device testing.
For catheter based systems see additional tests here.
For systems with integrated valves see additional tests here.
Acute Particulate Matter Evaluation
Balloon Rated Burst Pressure (RBP)
Durability Testing (Integrated Durability Assessment)
Durability testing is intended to determine the in-vitro lifetime, the anticipated failure modes, and potential failure consequences (e.g. immediate total loss of function or gradual degradation of function).Learn more
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
Experimental Flow Field Assessment – Digital Particle Image Velocimetry (DPIV)
Using Digital Particle Image Velocimetry (DPIV), pulsatile flow conditions in the immediate vicinity of the device can be analyzed to determine the viability of cardiovascular devices meeting regulatory standards. Triggers for disease (such as shear stresses and regions of stagnation) can be quantified with a high degree of accuracy. Advanced methods, including proper orthogonal decomposition, also capture the implicit fluid mechanical phenomenon of interest.Learn more
Pulsatile Flow Testing - Hydrodynamic Performance
Hydrodynamic Performance Pulsatile Flow Testing – Forward flow and regurgitant performance of the device will be assessed under physiological pulsatile flow conditions. Key indicators of valve performance such as Effective Orifice Area (EOA) and regurgitant fraction (RF) are determined.Learn more
Pump Performance Test
Pushability uses the proximal and distal load cell to measure the amount of force the distal tip of the guidewire sees when a known force is being applied to the product on the proximal end.Learn more
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
Simulated Use Testing Under Pulsatile Flow
Trackability uses the proximal load cell to measure the force to advance the device through a tortuous anatomy with or without the aid of a guiding accessory such as a guidewire, guide catheter, etc.Learn more
ISO 14708-5:2020 Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices
ViVitro Labs offers circulatory support device testing such as: pump performance, fluid dynamic analysis (flow visualization), cavitation observation, and system characterization
The testing will simulate the effects of changes in system performance on the “patient” (i.e., Pulse duplicator) and the effects of “patient” changes on system performance. The ViVitro Pulse duplicator will be appropriate to replicate conditions of both the normal and diseased patient populations and will replicate the patient’s native heart rates, and systolic/diastolic pressures and flows.
Testing will span the expected extremes of operation including the minimum blood flow and maximum blood flow, hypertension, hypotension, responses to changes in flow, pressure and possible inflow/outflow restrictions. A matrix of test conditions can be generated in order to characterize the system over the full range of operational limits. This can be split into testing different cardiac outputs, different beat rates of the native heart, different arterial loads, and finally some challenge cases which include the maximum flow rate achieved and restrictions on the inlet and outlet to the circulatory support device.