FDA clears St. Jude connector system for implanting CRT devices
The FDA has approved St. Jude Medical's connector 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.
The St. Paul, Minn.-based company said its 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 procedure a simpler process. In addition, the new system reduces the volume of the leads and device in the chest pocket.
The SJ4 connector system features a single connection between the CRT-D and the defibrillation lead and a single set screw. St. Jude Medical said its SJ4 connector system was designed to meet the draft International Organization of Standardization (ISO) IS-4 standard but will not be labeled as such until the standard is published, which is expected later this year.
The St. Paul, Minn.-based company said its 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 procedure a simpler process. In addition, the new system reduces the volume of the leads and device in the chest pocket.
The SJ4 connector system features a single connection between the CRT-D and the defibrillation lead and a single set screw. St. Jude Medical said its SJ4 connector system was designed to meet the draft International Organization of Standardization (ISO) IS-4 standard but will not be labeled as such until the standard is published, which is expected later this year.