In recent years, the development of drug-device combination products has brought about a step-change in certain parts of the medical device arena. Perhaps the most notable example has been the drug-eluting stent (DES) market, which saw explosive growth from $1.5bn to $5bn over a two year period. PC coatings have played a significant part in this area with the launch of Abbott Laboratories’ PC/dexamethasone coated Dexamet® stent, the second DES to be brought to market in Europe and Medtronic’s PC coated eluting Endeavor® DES system.
Vertellus Biomaterials is therefore well placed to offer its expertise in the development and commercialisation of ground-breaking drug-device combinations that offer clinical benefit through the controlled release of therapeutic agents.
Delivering a drug locally to the site of disease or injury can eliminate many of the side effects seen as a result of systemic drug administration and can increase efficacy. The site-specific delivery of drugs from coronary stents has been clearly demonstrated to significantly reduce restenosis rates, although more recent evidence is demonstrating the value of a truly biocompatible polymer coating such as PC, to minimise the risk of potentially fatal thrombus formation.
One of the first drug-eluting stents commercialised, Dexamet (now owned by Abbott Laboratories), uses a PC coating to elute the anti-inflammatory drug dexamethasone from the stent. More recently, Medtronic's anti-proliferative/anti-inflammatory eluting Endeavor® DES system has been launched in Europe.
These applications underscore the value that PC materials can bring to the medical device market.
PC Biomaterials can:
- adsorb high molecular weight drugs
- absorb low molecular weight drugs
- exhibit precise loading and controlled release
- remain (unchanged) on the device as a biocompatible coating once the drug is released
Furthermore, the flexible chemistry upon which PC polymers are based allows a wide range of monomers to be added to the formulation, in order to customise matrices and fine tune performance requirements according to the active being delivered and to meet customer needs.