Vertellus Biomaterials PC Technology™
PC coatings offer versatile solutions for controlled drug delivery. All PC products are stable, illness non-toxic and bio-inert materials with simple application and processing methods, which makes them easy to integrate into existing manufacturing processes.
All PC products have either FDA material master files or Vertellus Technical Files that have been assembled using FDA guidelines. Customers are provided with an FDA letter of access to Vertellus master files or use in-house Technical Files in the preparation of their regulatory submissions. This increases speed to market and in the case of US submissions, the 510(k) route can often be taken (depending upon device classification). Typical PC coatings and bulk materials are shown in the table below, which also outlines their individual characteristics and typical medical device applications.
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. 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.