News | May 16, 2013

St. Jude Medical Gains CE Mark for Ellipse and SJM Assura Defibrillators

Implantable defibrillators feature additional safety features aimed to elevate the standard of care

May 16, 2013 — St. Jude Medical Inc. has received CE Mark approval of its Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The new portfolio is designed to lower the risk for lead abrasion and to ensure high-voltage therapy delivery.

The Ellipse and SJM Assura family of devices feature the DynamicTx Over-Current Detection Algorithm, which automatically adjusts shocking configurations within the device to ensure the delivery of high-voltage therapy if an electrical short in one portion of the system were to occur. In addition, the Ellipse and SJM Assura portfolio of implantable defibrillators features 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 is designed to reduce the risk for lead-to-can abrasion, the most common type of lead insulation failure in the industry.

These 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.

“The annual rate of lead defects increases over time regardless of manufacturer, and insulation failure accounts for 70 percent of lead failures in older leads,” said Johan Vijgen, M.D., director of electrophysiology at Jessa Hospitals in Hasselt, Belgium. “With important safety features designed to ensure successful delivery of high-voltage therapy, these new devices offer my patients a higher standard of care.”

The Ellipse and SJM Assura devices also feature expanded protection against inappropriate and unnecessary shocks with SecureSense RV Lead Noise Discrimination, an algorithm that expands St. Jude Medical ShockGuard Technology. SecureSense RV Lead Noise Discrimination differentiates lead noise (over-sensing of electrical signals) from true ventricular tachycardia (VT) or ventricular fibrillation (VF) episodes requiring therapy.

The Ellipse ICD provides all of the features offered by the Fortify Assura ICD inside the smallest volume, high-voltage device on the market. The Ellipse ICD allows for 36 J in delivered energy, providing a downsized option without compromising on energy, longevity, safety or reliability.

The Assura family of devices allows St. Jude Medical to continue to offer 40 J in delivered energy and includes the Quadra Assura CRT-D, the Unify Assura CRT-D and the Fortify Assura ICD.

For more information: www.sjm.com

Related Content

CardioFocus Announces European CE Mark Approval of HeartLight Excalibur Balloon
Technology | Ablation Systems| October 10, 2017
October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Ball
The Apama Radiofrequency (RF) Balloon Catheter System.
News | Ablation Systems| October 02, 2017
October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held
Boston Scientific Launches Resonate Devices With HeartLogic Heart Failure Diagnostic
Technology | Implantable Cardioverter Defibrillator (ICD)| September 27, 2017
September 27, 2017 — Boston Scientific recently launched the Resonate family of...
Spectranetics Initiates Class I Recall for Bridge Occlusion Balloon Catheter
News | EP Lab| September 27, 2017
Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in...
Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD
Technology | Implantable Cardioverter Defibrillator (ICD)| September 22, 2017
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Overlay Init