St. Jude Medical, Inc. has announced CE Mark Approval of the Ellipse™ Implantable Cardioverter Defibrillator (ICD). Designed with feedback from more than 200 physicians from around the world, St. Jude says the Ellipse ICD provides the benefits of advanced features and power in the industry’s smallest high-energy ICD.
ICDs are advanced implantable cardiac devices that treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardia or ventricular fibrillation) that often lead to sudden cardiac death (SCD).
St Jude says 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 minimizing inappropriate shock,” said Dr. 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.
“St. Jude Medical has a strong commitment to ongoing investment in research and development initiatives, and routinely incorporates physician feedback in the planning and design of our devices,” said Eric Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “The launch of the Ellipse family of ICDs further enhances our robust and comprehensive offering of cardiac rhythm management devices which, along with our Unify Quadra CRT-D system, represents the most advanced portfolio of high voltage devices available in the industry.”
The full press release can be found here.
Source: St. Jude Medical Inc., Business Wire