New St. Jude Durata Wire May Have Problems
Problems may be cropping up with the newer wires in St. Jude Medical Inc.’s implantable heart devices, according to a recent study.
An analyst’s report on the company for Jefferies & Co. calls attention to a study that suggests that the Optim insulation used on the company’s newer Durata wires may erode faster than expected, according to the Associated Press (AP).
The company previously withdrew several other types of leads used to connect a patient’s heart to a defibrillator over concerns that the silicone insulation on those wires could erode, which might lead to a malfunction of the device.
St. Jude had introduced newer leads that were coated with the Optim material, which it hoped would reduce the risk of insulation abrasions. Optim is a proprietary copolymer of silicone and polyurethane.
No insulation problems with the Durata have been disclosed by the company. However, St. Jude was ordered by the Food and Drug Administration to collect data on patients implanted with Durata wires and Optim insulation, reports AP.