CE Mark For St.Jude’s Assura ICD/CRT-D Family With Shockguard™ Technology

In short

St. Jude Medical, Inc. has gained CE Mark approval for its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The Assura family of devices,


Earlier this year we covered the news that the FDA had cleared the Assura family of products, which feature Shockguard™ technology comprising three new algorithms, designed to help protect patients against inappropriate shocks while providing the highest amount of delivered energy. The improvements designed into the Assura family of ICDs 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.

The Fortify Assura device also offers enhanced ST segment monitoring which 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.

Physician comments

“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.

Company comments

“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.”

For more information, see the full press release from St.Jude Medical here.

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