Cardiovascular device development: drug-eluting stents and implantable devices for the treatment of heart failure--the view from the Circulatory System Advisory Panel.
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.
Laskey
Warren K
WK
Cardiology Division, University of New Mexico School of Medicine, MSC 10-5550, 1 University of New Mexico, Albuquerque, NM 87131, USA. warrenlaskey@earthlink.net
D026683:Advisory Committees; D023903:Coronary Restenosis / Q000517:prevention & control; D018795:Device Approval; D004867:Equipment Design; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D017239:Paclitaxel / Q000627:therapeutic use; D019736:Prostheses and Implants; D016032:Randomized Controlled Trials as Topic; D020123:Sirolimus / Q000627:therapeutic use; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus