A Medical Device Daily
St. Jude Medical (St. Paul, Minnesota) reported that the FDA approved what is being called the first medical device system that allows a single defibrillation lead connection between a cardiac resynchronization therapy defibrillator (CRT-D) and the leads that send electrical impulses to the heart to treat the symptoms of heart failure.
The new connector system, which includes the Durata defibrillation lead with the SJ4 connector and the Promote CRT-D with the SJ4 connector, is expected to make the overall procedure a simpler process. In addition, the new system reduces the volume of the leads and device in the chest pocket, which could lessen the risk of lead-to-can abrasion, a known complication.
The SJ4 connector system features a single connection between the CRT-D and the defibrillation lead and a single set screw. Current lead designs require three separate connections and four set screws. The St. Jude Medical SJ4 connector system was designed to meet the draft International Organization of Standardization IS-4 standard but will not be labeled as such until the standard is published, which is expected later this year.
As a requirement of the FDA approval, St. Jude Medical will conduct a post-approval study that will enroll up to 1,700 patients and follow the group for five years. The company will also be gathering data on this new connector system as part of its ongoing SCORE patient registry, designed to track long-term data on system performance for all products, including new technology.