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DISA Vascular has published the company’s initial in vivo elution studies of the Stellium (drug-eluting) stent.
This study has shown that despite in vitro data demonstrating slow, sustained release of paclitaxel from a bioabsorbable polymer,
the porcine coronary artery model demonstrated a sequence of medial necrosis, stent malapposition and late neointimal thickening.
These studies have shown that the therapeutic window for paclitaxel may be narrower than currently believed.
These results, along with the recently published studies highlighting high late onset sub-acute thrombosis rates with drug-eluting stents, emphasizes the importance of optimal dosing, short-term drug release and delivery substrate biocompatibility to achieve long-term product safety. The Stellium stent addresses the need for a new generation of safer stents by dramatically reducing drug-dose, optimizing the elution profile and removing the potential long terms dangers of (non-bioabsorbable) delivery polymers. The clinical phase of testing will begin in 2007, with the Stellium’s First-In-Man clinical trial evaluating the stent’s safety and efficacy.
The full article is available at: https://www.hmpcommunications.com/jic/displayArticle.cfm?articleID=article5997
Learn more about the next generation of drug-eluting stents including the latest results of the Stellium porcine trials:
Envisioning a Next Generation Drug Eluting Stent: Prospects for Novel Compounds and Methods of Stent–based Drug Delivery
Nicolas A.F. Chronos, MD, FRCP, FACC, FESC, FAHA, TCT 2006
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