This Small Business Innovation Research (SBIR) Phase II project is focused on designing, prototyping, and fully qualifying a proprietary manufacturing apparatus capable of applying a range of next-generation coronary stent coatings. First generation drug-eluting coronary stents have significantly improved clinical outcomes for heart patients, while concurrently highlighting the potential for substantial improvements. Next-generation methods are needed for improving the way drugs and other biologics are applied to the stent, as well as for active-agent release from the stent. The company successfully demonstrated in Phase I that its proprietary ElectroNanospray process could reproducibly apply nanocomposite drug/polymer coatings onto the intricate architecture of a coronary stent and could consistently meet preliminary specifications provided by a potential commercial partner. This Phase II project will extend that R&D by producing a manufacturing Apparatus designed to significantly improve process control features and throughput. Rigorous step-wise hardware-qualification experiments will generate test lots of coated stents for further characterization and validation by the same partner. Feedback will guide design iterations needed to optimize this unique manufacturing capability, with the goal of producing an apparatus that coats stents with a broad range of novel nanocomposite coatings and drug-release properties for preclinical testing and meets the stringent performance requirements for commercial manufacturing in a regulated environment.
Commercially, sales of drug-eluting coronary stents will exceed $6 billion in 2006. With the first products entering the market in 2003, this represents the fastest market introduction in medical device history. The drug-eluting stent showed that the body's inflammatory and scarring response to the implanted bare metal stent, which resulted in re-blockage of the artery, could be overcome by applying thin layers of drug-releasing polymers to the stent surface. The broader implications are that coatings that enable site-specific delivery of biologically active compounds could improve the clinical performance of a wide variety of medical device implants, not only for cardiovascular indications, but also for use in orthopedic, neurology and tissue engineering applications. In addition, using the drug-eluting stent as an example, they offer the possibility of bringing about the same or improved clinical outcomes as existing therapies, while reducing cost, hospital length of stay, and loss of productivity by the patient. The novel manufacturing apparatus proposed in this research will have the ability to create and apply engineered nanocomposite coatings to device implants that incorporate novel active agents and controlled-release properties not possible with today's conventional coating processes, thereby offering the possibility of improved clinical outcomes for a wide variety of diseases.
