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St. Jude Medical’s Connector System For Cardiac Resynchronisation Therapy Devices Receives US Approval

St. Jude Medical, Inc announced US Food and Drug Administration (FDA) approval of the medical device system which allows a single defibrillation lead connection between a cardiac resynchronization therapy defibrillator (CRT-D) and the wires (leads) which send electrical impulses to the heart to treat the symptoms of heart failure. The new connector system, that 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 device and leads in the chest pocket, that could lessen the risk of lead-to-can abrasion, a known complication. The SJ4 connector system features a single connection between the defibrillation lead and CRT-D and a single set screw. Present lead designs require three separate connections and four set screws. The SJ4 connector system was designed to meet the draft International Organization of Standardization (ISO) IS-4 standard. This will not be labeled as such until the standard is published that is expected later this year. “By simplifying the lead connection process, the physician will be able to reduce procedure time for both initial implants and future device replacements,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “The SJ4 connector system also requires less lead and device volume in the body than previous designs, which could reduce the risk of lead abrasion as well as provide additional comfort to the patient.” As a requirement of the FDA approval, the comapny will conduct a post-approval study which will enroll up to 1,700 patients and follow the group for five years. St. Jude Medical will also be gathering data on this new connector system as part of its ongoing SCORE patient registry which is designed to track long-term data on system performance for all products, including new technology. “We are pleased to be the industry leader in bringing this important new connector system to the US market,” said Dr. Fain. “We look forward to working with the FDA to track the long-term benefits that we believe this technology will provide.” The company will begin a limited release over the coming months and expects a full release of the product later this year. The company will also continue to offer its other standard connector systems so that physicians will be able to select a device configuration based on their preference and the individual needs of their patient.