Cardiovascular device development: lessons learned from pacemaker and implantable cardioverter-defibrillator therapy.
Pacemaker (PM) and implantable cardioverter-defibrillator (ICD) therapy are two examples of remarkable technological advances that have revolutionized cardiovascular device therapy. Understanding the history of early PM and ICD device development, recognizing the importance of the clinical data that was required to launch the current "era" of exponential device use, and appreciating the challenge of maintaining device innovation without sacrificing device reliability, are important lessons that may offer insights into future cardiovascular device development.
Maisel
William H
WH
Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA. wmaisel@partners.org
D002986:Clinical Trials as Topic; D017147:Defibrillators, Implantable / Q000009:adverse effects; D018795:Device Approval / Q000592:standards*; D004867:Equipment Design; D004869:Equipment Safety / Q000592:standards; D006801:Humans; D010138:Pacemaker, Artificial / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing