Drug-Eluting stents systems

Hausleiter J, Kastrati A, Wessely R, et al. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J 2005 26(1 5) 1475-1481. 

Clinical experience with nonpolymeric paclitaxel drug-eluting stent systems... 

Russell ME. The BSC drug-eluting stent systems polymer characteristics and drug delivery http //Www.tctmd.com/ csportal/ appmanagerActmd/main nfpb=true pagel abel=TCTMDC ontent hdCon=864064. 

Polymers—the optimal system for controlled drug-eluting stents... 

Marketed drug-eluting stents employing controlled drug delivery systems... 

The book is comprised of five sections with part I covering systemic and endoluminal therapy with an incisive overview of hemostasis and thrombosis part II covers local therapy with several chapters devoted to drug-eluting stents and restenosis therapies part III covers cell therapy and therapeutic angiogenesis and includes chapters on cell transplantation and clinical trials in cellular therapy part IV covers adjunctive pharmacotherapy with chapters devoted to various patient populations including those with heart failure, diabetes, atrial fibrillation, peripheral artery disease,... 

The FDA defines the PMOA for a drug eluting stent (DBS) is as a device [38, 39]. During the regulatory process CDER would be involved with the review of the pharmacologic agent and CDRH would review the stent platform, the delivery system and the carrier (polymer), if present. In Europe a DES would also be viewed as a medical device [15,40]. 

M.A.M. Beijk, J.J. Piek, XIENCE V everoUmus-eluting coronary stent system a novel second generation drug-eluting stent. Expert Rev. Med. Devices 4 (2007) 11-21. 

A. Abizaid, and J.R. Costa Jr, New drug-eluting stents An overview on biodegradable and polymer-free next-generation stent systems, Circ. Cardiovasc. Interv, 3 (4), 384-393,2010. 

Intra-arterial catheters have been used for different objectives, such as the placement of other devices like stents, the delivery of drugs to various targets in the cardiovascular system and the delivery of embolic materials to close arterial-venous fistulas. Drug therapy has also been combined with catheter ablation, pacemakers and cardioverter defibrillators in order to treat arrhythmias. On the other hand, implants for the reconstruction or functional replacement of cardiovascular components have been combined with drugs to prevent thrombosis. Finally, drugs to avoid restenosis have been widely employed in different devices such as drug-eluting stents. 

Udipi, K., Chen, M., Cheng, R, et al. Development of a novel biocompatible polymer system for extended drug release in a next-generation drug-eluting stent. J. Biomed. Mater. Res. A 85A, 1064-1071 (2008). doi 10.1002/jbm.a.31664... 

Bloomington, Indiana, U.S.A.) coated with escalating doses of paclitaxel (0,2, 0,7, 1.4, and 2.7 jig/mm2 of stent surface area) applied directly to stent surface. In both trials, there was a dose-dependent effect on the angiographic parameters of restenosis (64). However, clinical outcomes at 6 and 12 months were not improved in these studies (65). The subsequent Drug ELuting coronary stent systems in the treatment of patients with de noVo nativE coronaRy lesions... 

Overall, key takeaways from the nonpoly meric paclitaxel delivery studies were that despite their improvement of angiographic parameters, paclitaxel-eluting stents without a polymer carrier did not demonstrate a positive effect on clinical outcomes, as seen with polymer-based paclitaxel elution (65), discussed in the next section. Potential reasons for the failure of such an approach could be loss of drug to the systemic circulation prior to reaching the target site during the stent deployment procedure, variability associated with the dose delivered to the lesion, and lack of control over drug-release kinetics due to the absence of a polymer carrier. 

---