
Stents are metallic-slotted tubes that are widely used in clinical practice as implantable devices in coronary and peripheral arteries in order to maintain blood flow through diseased vessels. However the major challenge in coronary stenting has been the high rate of re-narrowing of the blood vessel (restenosis), which is documented to be 20-30%. More recently, drug-coated stents, which use a polymer coating as a carrier to deliver potent therapeutic drugs to reduce restenosis, have substantially improved patient outcome. The drug is incorporated in the polymer and is then released in a controlled manner after insertion of the stent. The use of polymer-coated stents is growing rapidly and has become one of the most exciting therapies in interventional cardiology. There are, however, a number of challenges with polymer-coated stents which need to be considered:
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| • | the ability of the polymer coating to hold a sufficient dose of the drug; |
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| • | being able to effectively control the release profile of the drug (timing and dose); | Click here for the drug release profile, Dual Release of Dexomethason and Rapamycin from a stent coated with PEP polymer |
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| • | the durability of the polymer coating; and | |
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| • | the long-term biocompatibility of the coating. | Click here to show the pre-clinical trial |
Our technology, programmable elution profile (PEP™) is based on a biostable polymeric coating. This coating has been developed to meet the above challenges. Pre-clinical trials of PEP™-coated stents have shown the coating is safe and not associated with any adverse reaction in the porcine coronary artery model at 28 or 90 days implantation.