New ICD Technologies
In an article published Wednesday in the New England Journal of Medicine, the cardiologist who sounded an early alarm on the later recalled Medtronic Sprint Fidelis leads warns that a soon-to-be-approved electrical component for implantable heart devices may prove dangerous to patients.
Dr. Robert G. Hauser of the Minneapolis Heart Institute argues that manufacturers and federal regulators have not adequately tested the new defibrillator connections, or leads, for potential short-circuiting problems. Like the Medtronic Sprint Fidelis leads, this new technology is viewed by the FDA as a change of an existing product and so does not require the same degree of testing that is required for a new product.
I think Dr. Hauser's point is not that this new technology, which will allow smaller heart devices to be implanted more comfortably in patients, is necessarily flawed or defective. Rather, he is contending that more testing is necessary before allowing this new technology to be used in more patients.
Given Dr. Hauser’s prophetic history, would it make some sense to hear him out?
- Why the FDA Failed Us in the Medtronic Lead Recall (post market surveillance of drugs and medical devices)
- More on the FDA as a Watchdog (more on post market surveillance using the Zimmer Durom Hip litigation as an example)
