Dublin - Medical device developer St Jude Medical has gained approval from the US Food and Drug Administration (FDA) as well as gaining the European CE Mark for its Durata defibrillation lead.
St Jude made the announcement at the 13th Annual International Boston Atrial Fibrillation Symposium in Boston, Massachusetts, 17-19 Jan.
The Durata lead uses Optim insulation, a hybrid silicone/polyurethane material unique to St. Jude Medical, which was created specifically for cardiac leads. Optim blends silicone's biostability and flexibility with the strength, tear resistance and abrasion resistance of polyurethane. This results in increased durability, as well as flexibility and handling characteristics that aid device implantation, according to St Jude.
Durata also has a soft silicone tip with a larger surface area and a slightly-curved right ventricle (RV) shock coil. This helps ease of use and handling, as explained by Stephen Stark, MD, clinical professor of medicine, UC Davis Medical Center Electrophysiology Laboratory in Sacramento, California.
A softer tip and curved coil "allow me more control during implant procedures, as well as more options for lead placement," said Stark.