The US Food and Drug Administration (FDA) approved a new implantable cardioverter defibrillator (ICD) system that is considerably less expensive than other ICDs.
ICDs are surgically implanted into the chest to sense heart function in people at risk of dying from sudden cardiac arrest. They automatically deliver an electrical shock when needed to restore normal heart rhythms.
"FDA is committed to helping patients get access to safe and effective new medical technology quickly, at affordable prices," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "Lower cost ICDs will mean that these critical, life saving devices will be more affordable and accessible for many patients who need them."
The new product, made by Biotronik, of Portland, Ore., has fewer features than currently marketed ICDs and costs $10,000, about half the price of standard ICDs. It is easier to program and simpler to use than standard models.
It provides high-energy (shock) therapy for life-threatening arrhythmias; however, it does not offer lower energy pacing therapies, which are also sometimes used to bring the heart back into normal rhythm.
The Biotronik device was approved approximately two months from the date the firm submitted its marketing application.
To provide additional information on the safety and effectiveness of the new ICD, FDA is requiring Biotronik to conduct a two-year post-approval study of 370 patients in whom the device is implanted.