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St Jude Medical announces CE Mark approval for Ellipse, SJM Assura devices

St. Jude Medical, a US-based medical device company, has announced CE Mark approval of its next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

The new portfolio is planned to lower the risk for lead abrasion and to ensure delivery of high voltage therapy.

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.

In addition, the next-generation Ellipse and SJM Assura portfolio of implantable defibrillators feature low friction coating on the device to reduce the friction between the device and leads.

St. Jude Medical Implantable Electronic Systems Division president Eric Fain said that the goal of the portfolio of devices is to bring implantable defibrillation reliability and patient safety to the next level.

The Ellipse and SJM Assura family of devices also feature expanded protection against inappropriate and unnecessary shocks with SecureSense RV Lead Noise Discrimination.

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.

Studies have shown that cardiac resynchronization therapy (CRT) can improve the quality of life for many patients with heart failure.