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news.St Jude Medical has received the FDA's approval for a medical device system that reportedly allows a single defibrillation lead connection between a cardiac resynchronization therapy defibrillator and the wires, or leads, that send electrical impulses to the heart to treat the symptoms of heart failure.
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According to the company, 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 reportedly reduces the volume of the leads and device in the chest pocket, which could lessen the risk of lead-to-can abrasion.
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.
St Jude Medical said that it will begin a limited release shortly and expects a full release of the product later in 2009.
Eric Fain, president of the cardiac rhythm management division at St Jude Medical, said: By simplifying the lead connection process, the physician will be able to reduce procedure time for both initial implants and future device replacements. 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.