The SJ4 connector system features a single connection between the device and the defibrillation lead, and a single set screw (used to tighten and secure the lead to the device).
With only a single connection and one set screw, the SJ4 connector has the potential to improve the implant procedure, may reduce the lead volume under the ICD in the chest wall and may improve patient comfort, said Cleveland Clinic’s Bruce Wilkoff, M.D., who is on the company’s physician lead review board and has sponsored research with St. Jude Medical, Inc. Dr. Wilkoff implanted the first Current Plus ICD with SJ4 connector on June 4, 2009. This design is intended to reduce the risk of incorrect connections of the lead to the ICD and reduce procedure time.
The SJ4 connector system is designed to meet the draft IS-4 standard as set forth by the ISO but will not be labeled as such until the standard is finalized, which is expected later this year. St. Jude Medical began launch of the SJ4 connector system after ISO-directed interchangeability testing among multiple manufacturers was completed. This testing was deemed an important step in ensuring that these new leads, which currently meet the drafted IS-4 standard, would be compatible with future implanted devices.
Simplifying the lead connection process is one of many design features we have incorporated as part of our commitment to making procedures safer for patients and more efficient for physicians, from implant through follow-up, said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. This aligns with our strategy of reducing lead risks and increasing reliability, which includes technology designed to reduce lead-to-can abrasion and sensing of far-field ventricular signals in the atrium.
The Current Plus ICD was approved by the FDA in April 2009, along with the company’s Promote Plus cardiac resynchronization therapy defibrillator (CRT-D), which are compatible with the Durata SJ4 defibrillation lead. As with previously announced leads in the Durata lead family, the Durata lead with SJ4 connector features a soft silicone tip and Optim insulation, a hybrid insulation material that provides increased abrasion-resistance and durability, along with the flexibility and handling characteristics that facilitate device implantation.
Both devices are built on the St. Jude Medical Unity platform, a consolidated hardware and software unified device interface, and include advanced safety features and algorithms for improved patient management, including TailoredTherapy features that allow physicians to customize therapy to individual patient needs. The devices also feature improved lead monitoring capabilities, including daily checks of all pacing and shock configurations, and have the ability to inform the patient’s clinic of any critical system changes.
As a requirement for FDA approval, St. Jude Medical is conducting a post-approval study featuring the SJ4 connector that will enroll up to 1,700 patients and follow them 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.
