FDA green-lights St. Jude ICDs, CRT-D
St. Jude Medical received FDA approval for two of its implantable technologies: the Ellipse implantable cardioverter-defibrillator (ICD) and the Assura portfolio of ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds).
According to Saint Paul, Minn.-based St. Jude, the Ellipse ICD is a small ICD, which may allow for a smaller incision and pocket size. The design includes an angled header and rounded edges that allow the lead to wrap around the device once connected. St. Paul, Minn.-based St. Jude said the company involved physician focus groups in the design process.
The Assura portfolio features an algorithm that provides advanced sensing options designed to reduce the incidence of inappropriate shocks for patients with these devices. Called the SecureSense RV Lead Noise Discrimination algorithm, it is expected to assist physicians by providing advanced alerts and more proactively lowering the risk of lead-related complications by withholding tachycardia therapy in the presence of lead noise.
The Ellipse ICD also features SecureSense RV Lead Noise Discrimination algorithm, which expands the St. Jude’s ShockGuard Technology, differentiates lead noise from true ventricular tachycardia or ventricular fibrillation episodes. The ShockGuard technology also features programming that distinguishes between rhythms requiring defibrillation therapy and those that do not, such as benign arrhythmias.
The FDA approved the Assura technology May 8 and the Ellipse technology May 9.
According to Saint Paul, Minn.-based St. Jude, the Ellipse ICD is a small ICD, which may allow for a smaller incision and pocket size. The design includes an angled header and rounded edges that allow the lead to wrap around the device once connected. St. Paul, Minn.-based St. Jude said the company involved physician focus groups in the design process.
The Assura portfolio features an algorithm that provides advanced sensing options designed to reduce the incidence of inappropriate shocks for patients with these devices. Called the SecureSense RV Lead Noise Discrimination algorithm, it is expected to assist physicians by providing advanced alerts and more proactively lowering the risk of lead-related complications by withholding tachycardia therapy in the presence of lead noise.
The Ellipse ICD also features SecureSense RV Lead Noise Discrimination algorithm, which expands the St. Jude’s ShockGuard Technology, differentiates lead noise from true ventricular tachycardia or ventricular fibrillation episodes. The ShockGuard technology also features programming that distinguishes between rhythms requiring defibrillation therapy and those that do not, such as benign arrhythmias.
The FDA approved the Assura technology May 8 and the Ellipse technology May 9.