St. Jude Medical is introducing a new connector system, called SJ4, designed to minimize the number of connections between cardiac leads and the company’s AICDs. For now the new connector will be used only in Current Plus AICD model, but our guess is that if accepted by surgeons, cardiologists and radiologists, the connector might be making its way into other company devices.
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). Previous defibrillator lead designs required three separate connections and four set screws. The reduced number of lead connections also lessens the risk of lead-to-can abrasion, a known complication that can occur in patients who have an implantable 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 St. Jude Medical SJ4 connector system is designed to meet the draft IS-4 standard as set forth by the International Organization of Standardization (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(R) Plus cardiac resynchronization therapy defibrillator (CRT-D), which are compatible with the Durata(R) 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(R) insulation, a hybrid insulation material that provides increased abrasion-resistance and durability, along with the flexibility and handling characteristics that facilitate device implantation.