St. Jude Medical has received CE Mark Approval for its Ellipse implantable cardioverter defibrillator, currently the world’s smallest high-energy ICD. The device’s shape was actually a product of work with more than 200 doctors who used clay to craft their ideal implant shapes.
Though looking much like other similar devices, the improvements to the shape of the ICD were made to increase comfort for the patient and to make implantation an easier process for the surgeon.
From SJM’s announcement:
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.
Within its unique design, the device contains new features in addition to the industry-leading feature set provided in the Fortify(TM) ICD. These features include expanded ShockGuard(TM) technology for protection against inappropriate and unnecessary therapy, high energy delivery, CorVue(TM) congestion monitoring, and enhanced ST Monitoring to offer greater insight into ischemia-related ventricular arrhythmias.
Additionally, the Ellipse ICD adds SecureSense(TM) 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 (VT) or ventricular fibrillation (VF) 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.
Press release: St. Jude Medical Announces CE Mark Approval of Smaller ICD with Physician-Inspired Shape…
