St. Jude Brings New Defibrillators to United States

St. Paul, Minn.-based St. Jude Medical Inc. has earned U.S. Food and Drug Administration approval for its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new devices are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery. The devices gained CE Mark in May for commercialization in Europe.

The Ellipse and SJM Assura family of devices feature the Dynamictx over-current detection algorithm, designed to automatically adjust shocking configurations to ensure the delivery of high-voltage therapy even if an electrical short in one portion of the system occurs. The devices also have a low-friction coating on the can, which reportedly has been demonstrated in testing to significantly reduce friction between the device and leads. As such, the low-friction coating provides an extra layer of insulation and is designed to reduce the risk for lead-to-can abrasion, the most common type of lead insulation failure in the industry.

“The new safety features in these devices are an excellent example of innovation that improves patient safety,” said Anne B. Curtis, M.D., chairwoman of the department of medicine with the University at Buffalo, N.Y. “The Dynamictx feature in the new Ellipse and SJM Assura devices provides an additional safeguard to ensure the patient receives live-saving therapy delivery even if an electrical short were to occur. In addition, St. Jude Medical is the first company to help address the problem of lead-to-can abrasion by providing increased insulation on the ICD device itself, rather than the lead.”

“St. Jude Medical strives to deliver the highest levels of patient safety,” said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “The new Ellipse ICD and SJM Assura family of devices support those efforts by providing added features that ensure effective therapy delivery. We are pleased that the FDA approved these devices, allowing us to bring important safety and system reliability enhancements to patients.”