Ellipse ICD gets CE mark approval


On 16 April, St Jude Medical announced CE mark approval of its Ellipse implantable cardioverter defibrillator (ICD). Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD provides the benefits of advanced features and power in the industry’s smallest high-energy ICD.

The Ellipse ICD’s unique shape was conceptualised by physicians during focus groups in which they crafted in clay their vision for the ideal device design. The physician-inspired shape is unlike any currently available, with each of the enhancements designed to increase patient comfort or make the device easier to implant. The angled header and rounded edges were designed to improve the way a cardiac lead wraps around the device once connected, which can result in a smaller pocket for the device.

“Its thinness, longevity and new discrimination algorithms constitute the answers to the three main concerns of patients and their doctors: decreasing the volume of the can, reducing the risk for infection during ICD replacement and minimising inappropriate shock,” said L R C Dekker, cardiologist from the Cardiac Center of the Catharina Hospital in Eindhoven, The Netherlands, who implanted the first Ellipse ICD in Europe.

The device contains new features like ShockGuard technology for protection against inappropriate and unnecessary therapy, high energy delivery, CorVue congestion monitoring, and enhanced ST monitoring to offer greater insight into ischaemia-related ventricular arrhythmias.

Additionally, the Ellipse ICD adds SecureSense RV lead noise discrimination, a new algorithm that offers a strong set of lead monitoring capabilities. The new feature can differentiate lead noise from true ventricular tachycardia or ventricular fibrillation episodes, which provides the ability to automatically withhold tachycardia therapy in the presence of lead noise. The new feature is expected to help physicians more proactively lower the risk of lead-related complications.