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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Remember me for one month. Next to calcium alginate as a natural hydrogel, synthetic polymers with good mechanical and long-term stability were also used. Furthermore, the hydrogel characteristics were important for Asm transfer and diffusion into hydrogels.

PAAm was synthesized by radical polymerization. Enter your account email address to request a password reset: In vivo characteristics may also differ from in vitro results. Table 2 Particle quantification after simulated anatomic passage.

It is intended to provide a starting point from which to select and investigate securement test options. Drug transfer from coated balloon catheters to different simulated vessel walls was evaluated and compared to a silicone tube. FORMAT Single User Subscription Site License Subscription BOOKS All Books PACKAGES All Packages EDITION to PUBLISHER.

ASTM F2394 – 07(2017)

Considerably lower PTX was delivered into hydrogel-based vessel models. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory requirements prior to use. Combining values from the two systems may result in non-conformance with the standard. A hydrogel is a network of polymer chains that are hydrophilic and should be more appropriate. This corresponds to different amounts of PTX wash-off from the vessel models after 1 min by a simulated blood stream see Table 1 or Fig.

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Catheter Torque Test

For an assessment of this study, the total drug delivery upon dilation retention into the hydrogel and wash-off asmt from the hydrogel compartment by a simulated blood stream and the residual load on the balloon were analyzed. An example test apparatus is given in 7. The guide proposes a set of options to consider when testing stent securement.

Please login to your authorized staff account to use this feature. The guiding catheter was then flushed with 20 mL methanol. In summary, the hydrogel material was crucial for the total drug delivery upon dilation Fig.

ASTM-F, –

After complete gelation, the metal rod was removed from the flow-through cell and a simulated artificial vessel wall was obtained. The Paccocath technology with PTX embedded in hydrophilic iopromide coating increases the solubility and thus the transfer of PTX to the vessel wall. We have been working on polymerized ionic liquids PILs which are able to form hydrogels. The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints.

Historical Version s – view previous versions of standard. All samples were quantified by means of Asttm after a 1: Extraction of the balloon catheter in methanol resulted in a PTX content of 1. 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.

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Received 16th OctoberAccepted 8th January 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.

Thus, the drug diffused f234 the vessel model or adhered on the vessel wall and was not released in one minute into the medium. In conclusion for the simulated use of DCB, the total drug delivery upon dilation is different for the used hydrogels simulating the vessel wall. Drug-coated balloon catheters are a novel clinical treatment alternative for coronary and peripheral artery diseases.

Torque Sensor Application – Catheter Torque Test

The total PTX delivery upon dilation composed of drug transfer into the vessel model hydrogel and drug wash-off from the hydrogel compartment after 1 min by a simulated blood stream. In both cases, similar transfer rates for paclitaxel upon dilation were detected. A shorter dilation time results in partial drug release. It is intended to provide a starting point from which to select and investigate securement test options.