Medical device maker St. Jude Medical reported that regulators both here and in Europe have approved its new Durata lead wires, which attach implantable defibrillators to the heart and regulate heart beat. Ostensibly, the Durata leads have a softer tip and slightly curved coil that will make these defibrillator leads more flexible and durable.
There were reports late last year that the Riata leads, which are similar to the Medtronic Sprint leads that were recalled in October, broke and perforated patients’ hearts in at least four reported cases. St. Jude chose a different path and did not recall the Riata defibrillator leads. It will be interesting to compare the St. Jude defibrillator leads with the recalled Medtronic leads (with the benefit of hindsight) to see whether the St. Jude’s leads are just as defective as the Medtronic leads.
As I have written before, there is plenty of reason to be concerned that the St. Jude leads have the very same defects as the Medtronic defibrillator leads.