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FDA approves Ellipse ICD

FDA approves Ellipse ICD

The FDA has approved St Jude Medical’s Ellipse implantable cardioverter defibrillator (ICD). According to St Jude Medical, this device is the industry’s smallest high-energy ICD and it has been designed with feedback from more than 200 physicians from around the world.

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

“The St Jude Medical Ellipse ICD not only will streamline the implant procedure and improve patient comfort with its innovative design, but the device adds safety features with its new discrimination algorithms intended to minimise inappropriate shocks,” said Rahul N Doshi, Fullerton Cardiovascular Medical Group, California, USA.

The Ellipse ICD features SecureSense RV Lead Noise Discrimination, an algorithm that expands St Jude Medical ShockGuard technology, differentiating lead noise (over-sensing of electrical signals) from true ventricular tachycardia or ventricular fibrillation episodes requiring therapy. The technology is expected to assist physicians by more proactively lowering the risk of lead-related complications through its ability to automatically withhold tachycardia therapy in the presence of lead noise.

The Ellipse ICD provides all of the industry-leading features offered by the Fortify Assura ICD inside the smallest volume, high-voltage device on the market. The Ellipse ICD allows for 36 J in delivered energy, providing a downsized option without compromising on energy, longevity, safety or reliability. Similar to the Fortify Assura ICD, the Ellipse ICD adheres to the International Standards Organization (ISO) DF4 connector specification. The DF4 connector reduces the number of connections between the defibrillation lead and the device. St Jude Medical was the first manufacturer to offer DF4 technology in early 2009.

“We feel collaboration with physicians in regards to the planning and design of our devices is imperative in order to develop truly breakthrough technologies,” said Eric S Fain, president, St Jude Medical Cardiac Rhythm Management Division.