FDA approves next-generation devices with new safety features
St. Jude Medical announced FDA approval of the next-generation Ellipse and SJM Assura portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. The new devices are designed to lower the risk for lead abrasion and to ensure high-voltage therapy delivery, according to a press release.
The Ellipse and SJM Assura devices feature the DynamicTx Over-Current Detection Algorithm, which automatically adjusts shocking configurations to ensure the delivery of high-voltage therapy. In addition, the devices have low-friction coating on the device can, which has been demonstrated to reduce friction between the device and leads. The low-friction coating provides an extra layer of insulation and is designed to reduce risk for lead-to-can abrasion, according to information in the release.
Anne B. Curtis
“The DynamicTx feature in the new Ellipse and SJM Assura devices provides an additional safeguard to ensure the patient receives life-saving therapy delivery even if an electrical short were to occur,” Anne B. Curtis, MD, chairman of the department of medicine at University of Buffalo, stated in the release.
Other device features include expanded protection against inappropriate and unnecessary shocks with SecureSense RV Lead Noise Discrimination; the capability to provide remote patient alerts over the Merlin.net Patient Care Network; and the Durata defibrillation lead with Optim lead insulation.