March 28, 2020

ASTM F2394 PDF

ASTM-F › Complete Document History Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System. Standard Number, ASTM F – 07(). Title, Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted. What kind of stent retention (dislodgement) force value is used in the industry for accepting finished product? This is for a coronary stent. The testing is.

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The poly VEImBr hydrogel shows strong swelling behavior in methanol which was used to extract the drug from the hydrogel.

Calcium alginate and polyacrylamide hydrogels were used as tissue models for the simulated anatomic implantation process. The estimated mechanism from DCB involves the delivery of particles to the inner lumen of coronary arteries, the release of particles or coating fragments in the coronary arteries.

Click here to download full list of books. PAAm was synthesized by radical polymerization. Within the first hour, the concentration decreases dramatically. Extraction of the balloon catheter in methanol resulted in a PTX content of 1. Silicone tube only balloon type 2calcium alginate trial 1: In the case of calcium alginate as the vessel wall, a PTX content in the hydrogel of Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided as part of the standard.

It is intended to provide a starting point from which to select and investigate securement test options. Drug delivered in the silicone tube was extracted with methanol The guide proposes a set of options to consider when testing stent securement.

The guide proposes a set of options to consider when testing stent securement. Link to Active This link will always route to the current Active version of the standard.

In vivo characteristics may also differ from in vitro results. Silicone tubes as a vessel model were not very suitable because they are not similar to physiological uptake behavior.

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Historical Version s – view previous versions of standard. The guiding catheter was then flushed with 20 f22394 methanol. This guide is intended to aid investigators in the design, development, and in vitro characterization axtm pre-mounted, unsheathed, balloon-expandable stent delivery systems.

For an assessment of this study, the total drug delivery upon dilation retention into the hydrogel and wash-off release from the hydrogel compartment by a simulated blood stream and the residual load on the balloon were analyzed.

Drug transfer into the vessel model Fig.

ASTM F2394 – 07(2017)

Combining values from the two systems may result in non-conformance with the standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other.

Consequently, there was still Search book title Astmm keywords for book title search. Table 2 Particle quantification after simulated anatomic passage. Drug residue on the balloon Fig.

Thus, the drug diffused into the vessel model or adhered on the vessel wall adtm was not released in one minute into the medium. Thus, their potential could not be fully explored. Calculated curves for PTX tissue concentration as function of time are provided in the literature. In conclusion, the PTX transfer upon dilation depends on the coating of the balloon and the used vessel model simulating the vessel wall. During balloon inflation, the blood flow in the vessel is interrupted and therefore expansion can only be maintained up to one minute.

In vivo characteristics may also differ from in vitro results. As before, a short wash-off time drug release after one minute was chosen to simulate the drug behavior after pass through the tracking model.

The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints.

Torque Sensor Application – Catheter Torque Test

The PTX transfer into f2349 vessel models are listed in Table 1. An example test apparatus is given in 7. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. A similar value for calcium alginate as the vessel model was found PTX content of 2.

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ASTM-F, –

The vessel-simulating flow-through cell was combined with a model coronary artery pathway to estimate drug loss during simulated use in an in vitro model. The balloon was almost completely unloaded. An example test apparatus is given in 7. Referenced Documents purchase separately The documents listed below are referenced within the subject standard but are not provided ashm part of the standard.

Drug-coated balloon catheters are a novel clinical treatment alternative for coronary and peripheral artery diseases. There are different possibilities for interpretation of the observed results.

Catheter Torque Test

Thus, the highest drug wash-off after 1 min was achieved in case of calcium alginate as the vessel model. Print 1 2 3 4 5 page sstarting from page current page. The solution was mixed using a Vortex and after a short reaction time 1—2 minthe flow-through cell containing the metal rod was filled with the polymerizing solution. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. Moreover, the diffusion of PTX into the vessel wall occurs at various rates, which may be related with the cross-linker content.

Complications are occlusions of small vessels or capillaries. Microporous balloon surfaces with Shellac coating technology can be inflated up to one minute and achieve total drug release. This could be overcome by r2394 other drug candidates or models showing, for example, fluorescence.