FDA Approval For St. Jude’s Ellipse™ and Assura™ ICD/CRT-Ds

Last month St. Jude Medical, Inc. told us it had gained CE mark approval for its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Now it’s confirmed FDA approval of the devices which are designed to lower the risk of lead abrasion and to ensure high-voltage therapy delivery.

Background

The Ellipse and SJM Assura family of devices feature the DynamicTx™ Over-Current Detection Algorithm, which automatically adjusts shocking configurations to ensure the delivery of high-voltage therapy even if an electrical short in one portion of the system were to occur. In addition, the next-generation Ellipse and SJM Assura portfolio of implantable defibrillators have a low-friction coating on the device can, which has been demonstrated in testing to significantly reduce the 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 St. Jude Medical high-voltage portfolio also features the Durata™ defibrillation lead with Optim™ lead insulation, a device never to be found far from the headlines as it continues to shrug off the troublesome reputation of its Riata and Riata ST antecedent.

Physician comments

“The new safety features in these devices are an excellent example of innovation that improves patient safety,” said Dr. Anne B. Curtis, Chairman of the Department of Medicine with the University at Buffalo. “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.”

These advanced technologies provide preventative and adaptive capabilities to address potential failures that can result in the inability to deliver high-voltage therapy when needed, especially in systems using silicone-only insulated defibrillation leads, which are known to be at higher risk of abrasion. It is estimated that over 400,000 silicone-only insulated defibrillation leads from all manufacturers remain active worldwide.

Company comments 

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

Full release here

Source: St. Jude Medical, Inc., Business Wire