News | December 31, 2012

St. Jude Medical Gains CE Mark for Assura Implantable Defibrillators Including New Quadripolar Device

Assura devices feature three new algorithms, more power and extended longevity

Ce mark St Jude Medical Assura Fortify ICD Unify CRT-D Quadra CRT-D

December 31, 2012 — St. Jude Medical Inc. (announced European CE mark approval of the Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The Assura family of devices, featuring Shockguard technology has three new algorithms that help protect patients against inappropriate shocks while providing the highest amount of delivered energy. These improvements are projected to reduce inappropriate therapy by 74 percent, allowing for more effective therapy. Products currently available in Europe include the Quadra Assura CRT-D, Unify Assura CRT-D and Fortify Assura ICD.

ICDs are implantable cardiac devices that treat abnormally fast, potentially lethal heart rhythms that can lead to sudden cardiac death (SCD) if left untreated. A CRT-D device resynchronizes the beat of the heart’s lower chambers, which often beat out of sync in heart failure patients. A CRT-D also provides back up treatment for SCD, which is a risk factor associated with certain types of heart failure.

All Assura devices can produce 40 Joules (J) of energy — the highest delivered energy available. The devices include expanded ShockGuard technology for protection against inappropriate and unnecessary shocks, CorVue congestion monitoring and algorithms including SecureSense RV lead noise discrimination, which offers physicians advanced alerts and helps proactively lower the risk of lead-related complications by automatically withholding tachycardia therapy in the presence of lead noise (an over-sensing of electrical signals).

The Fortify Assura device also offers enhanced ST segment monitoring (which tracks electrical changes between heartbeats). Monitoring of the ST segment helps indicate conditions such as ischemia, which happens when blood flow and oxygen to the heart muscle is obstructed. ST segment monitoring in an ICD prior to therapy for ventricular arrhythmias can offer greater insight into the cause of these dangerous heart rhythms.

“With the three new discriminators and highest amount of delivered energy, the Assura devices provide the ideal combination of intelligence and strength. These devices offer unique features that I believe will help protect my patients from inappropriate shocks and provide greater defibrillation therapy assurance,” said Dr. Klaus-Jürgen Gutleben, Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany.

The three new Assura devices available in Europe are:

  • Quadra Assura CRT-D – Featuring first-to-market quadripolar pacing technology from St. Jude Medical, the Quadra Assura CRT-D is designed to address common pacing complications such as phrenic nerve stimulation and high pacing thresholds, which can result in fewer surgical revisions, shorter procedure times and decreased fluoroscopic exposure.
  • Unify Assura CRT-D – Keeping the well-received shape of previous generations of Unify devices, the Unifiy Assura CRT-D has the smallest footprint in the industry for reduced incision size.
  • Fortify Assura ICD – Offering enhanced ST monitoring, the Fortify Assura ICD also has the highest delivered energy of any ICD available.


While the majority of shocks delivered by ICDs and CRT-Ds are considered appropriate and life-saving, the expanded ShockGuard technology, included in all CE mark approved Assura products, provides more accurate sensing and can differentiate between rhythms that require defibrillation and those that do not. The new algorithms and enhanced detection capabilities discriminate between lead noise and arrhythmias that require therapy, as well as which heart chamber is causing the arrhythmia. The new algorithms also detect and alert to episodes of oversensing due to lead noise and distinguish small electrical disruptions from real episodes that warrant life-saving treatment.

The Assura family of devices allows for expanded ST segment monitoring through the Patient Care Network, a system that allows patients to be monitored from home. This system provides timely information to clinics and ultimately allows for better management of patients with arrhythmias.

“St. Jude Medical understands patients’ needs vary, which is why we are excited to add three new defibrillation technologies in Europe to our complete portfolio of cardiac rhythm management devices,” said Eric S. Fain, M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “The Assura line of devices was designed for safety, reliability and extended longevity to help physicians best treat their patients.”

Across Europe SCD is estimated to affect between 180,000 and 450,000 people annually, according to meta-analysis conducted by the Sudden Cardiac Arrest Thought Leadership Alliance (SCATLA).

For more information: visit

Related Content

Medtronic Begins Pilot Study of Investigational Extravascular ICD System
News | Implantable Cardioverter Defibrillator (ICD) | August 09, 2018
Medtronic plc announced the start of a pilot study of its investigational Extravascular Implantable Cardioverter...
ICD Placements Not Meeting Medicare Coverage Criteria Decline After Overuse Investigation Announced
Feature | Implantable Cardioverter Defibrillator (ICD) | July 11, 2018
Placement of implantable cardioverter defibrillators (ICDs) not meeting Centers for Medicare and Medicaid Services (CMS...
New Tool Predicts Benefits and Risks of Implantable Defibrillator for Heart Failure Patients
News | Implantable Cardioverter Defibrillator (ICD) | July 02, 2018
University of Washington (UW) Medicine cardiologists have developed a tool to predict which heart-failure patients...
Real-World Data Demonstrates Success Of Smart Pass Filter on Boston Scientific S-ICD System
News | Implantable Cardioverter Defibrillator (ICD) | May 16, 2018
Boston Scientific announced results from an analysis of the LATITUDE database evaluating the successful reduction of...
Online Message Board Advice on ICDs Reflects Inaccuracies
News | Implantable Cardioverter Defibrillator (ICD) | April 13, 2018
April 13, 2018 — Medical advice about implanted cardiac defibrillators obtained via an online message board appears t
Biotronik U.S. to Distribute Aziyo ECM Envelopes
News | Implantable Cardioverter Defibrillator (ICD) | April 12, 2018
Biotronik U.S. and Aziyo announced a strategic agreement allowing Biotronik to distribute Aziyo's CanGaroo...
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...
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...
Predictive Models May Help Determine Which Patients Benefit From ICDs
News | Implantable Cardioverter Defibrillator (ICD) | July 06, 2017
Two predictive models may help cardiologists decide which patients would most benefit from an implantable cardioverter...
Videos | Implantable Cardioverter Defibrillator (ICD) | June 01, 2017
Lucas Boersma, M.D., Ph.D., FESC, St.
Overlay Init