Drug-eluting medical devices

A. Concheiro, and C. Alvarez-Lorenzo, Chemically cross-linked and grafted cyclodextrin hydrogels From nanostructures to drug-eluting medical devices, Adv. Drug. Deliv. Rev., 65 (9), 1188-1203,2013. 

A1 Lamee K and Cook D. Polymer coating techniques for drug eluting stent. Medical device technology 2003 http /www.medicalde vicesonline.com/ mdt/articledetail.j se =52234. 

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]. 

Polyvinyl chloride (PVC) resin is widely used in our daily lives and is essential for the production of plastics used in the manufacture of food gloves/" ° " medical devices/" " furniture, flooring, and so on. PEs, particularly di(2-ethylhexyl)phthalate (DEHP), are extensively used as plasticizers to increase the flexibility of PVC products however, it has been reported that DEHP was easily eluted from PVC products into food, drugs, and body fluids. DEHP is considered to exhibit reproductive and developmental toxicity,carcinogenicity, and testicular toxicity. It was also found to affect the reproductive organs and fertility. 

Medical Device Technology 14, No. 1, Jan.-Feb.2003, p. 12-4 POLYMER COATING TECHNIQUES FOR DRUG-ELUTING STENTS... 

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