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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In vivo characteristics may also differ from in vitro results. The guide proposes a set wstm options to consider when testing stent securement.

Next to calcium alginate as a natural hydrogel, synthetic polymers with good mechanical and long-term stability were also used. Thus, their potential could not be fully explored.

Enter your account email address to request a password reset: 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. Drug residue on the balloon.

Torque Sensor Application – Catheter Torque Test

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.

Consequently, there was still Over a period of one minute, a contact between the expanded balloon and simulated vessel wall is established, thus allowing transfer of PTX particles. Moreover, the diffusion of PTX into the vessel wall occurs at various rates, which may be related with the cross-linker content. Combining values from the two systems may result in non-conformance with the standard. The PTX transfer into the vessel models are listed in Table 1. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other.

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ASTM-F, –

An example test apparatus is given in 7. Paclitaxel may dissolve on contact with the hydrogel compartment and diffuse into the gel. Calculated curves for PTX tissue concentration as function of time are provided in the literature. Please login to f294 authorized staff account asfm use this feature. However, considerably less drug on the balloon catheter surface were analyzed in the cases of dilation in calcium alginate In comparison to a simple silicone tube their properties can be easily modified simulating different types of tissue.

The wash-off from the alginate hydrogel was high drug release after 1 min by a simulated blood stream: Historical Version s – view previous versions of standard.

ASTM F2394 – 07(2017)

To date, there are only a few in vitro studies presented, characterizing and describing the simulated use of drug coated balloon catheters in an in vitro vessel model. To conclude, the main PTX transfer during balloon expansion occurred due to prevailing mechanical forces. A similar value for calcium alginate as the vessel model was found PTX content of 2.

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Land Use and Development. All samples were quantified by means of HPLC after a 1: The options cover pre-test treatments, possible stent securement tests, and relevant test endpoints. However, expansion of the balloon in calcium alginate yielded only 0.

Catheter Torque Test

Silicone tubes as a vessel model were not very suitable because they are not similar to physiological uptake behavior. Dissolution depends on solubility of the used drug in 0. This guide is intended to aid investigators in zstm design, development, and in vitro characterization of pre-mounted, unsheathed, balloon-expandable stent delivery systems.

In conclusion, the PTX transfer upon dilation depends on the coating 2f394 the balloon and the used vessel model simulating the vessel wall.

Within the first hour, the concentration decreases dramatically. The Paccocath technology with PTX embedded in hydrophilic iopromide coating increases the solubility and thus the transfer of PTX to the vessel wall.