Bioabsorbable drug-coated devices deliver an acute dosage of drugs to specific treatment sites in a manner that prevents systemic drug delivery. This enables clinicians to treat a lesion site with specific drugs that may cause an adverse reaction if delivered systemically. Additionally, the bioabsorbable drug-coated device may speed up the healing process due to a more localized high concentration of the drugs. Because the device typically dissolves within 12-18 months, restenosis and clotting can be greatly reduced. Additionally, this device eliminates the metal stent interference problem for heart imaging post procedure.
A bioabsorbable device needs to have a radial strength that is great enough to expand and also great enough to properly place it against the treatment site. This way, drugs are correctly eluted through the tissue and not the bloodstream. In addition, the chronic radial force needs to be strong enough to secure the device in place over time.
Our RX fixture integrates with Electromechanical testing systems and is used to accurately measure radial forces and determine radial strength of bioabsorable devices. Unlike compression platens or fixtures that use vee blocks, which can cause uneven deformation of the bioabsorbable device, the fixture uses a segment approach to measuring force and deformation. Additionally, data is generated to determine the length of time the device can maintain its radial strength since this is a critical device requirement. As with all tests on the RX systems, Bluehill® Software generates standard reports for regulatory submissions that simplify approval processes.