abstract
- The development of sirolimus and paclitaxel-eluting stent delivery systems proved successful in reducing restenosis rates to single digit levels compared to bare metal stents, although the long-term safety of the latter devices was not assessed in these premarket applications. Implantable devices for the treatment of patients with advanced congestive heart failure improved short-term measures of circulatory function but underscored the role of properly conducted randomized controlled clinical trials. All of these examples highlight the critical role of valid scientific evidence in the regulatory process for cardiovascular device development.