St. Jude Medical wins FDA approval for Ellipse ICD, Assura CRM line
St. Jude Medical (NYSE:STJ) landed a pair of FDA wins in its cardiac rhythm portfolio, one for the Ellipse implantable cardiac defibrillator and the other for its Assura line of ICDs and cardiac resynchronization therapy defibrillators.
The St. Paul, Minn.-based device giant called the Ellipse the " the industry’s smallest high-energy ICD," having been designed with feedback from more than 200 physicians from around the world. The Ellipse device won CE Mark approval in the European Union last month.
St. Jude, in a separate release, also announced approval for its Assura line of ICDs and CRT-Ds, designed to help "protect patients from unnecessary defibrillation therapy."
Both the Ellipse and Assura devices feature SecureSense and ShockGuard technology that aims to reduce unnecessary shocks.
"For some patients, the fear of receiving a shock can either prevent them from receiving a potentially life-saving device, or cause anxiety that reduces their quality of life once they receive the device," CRM president Eric Fain said in prepared remarks. "These devices directly address this patient concern and provides physicians additional tools to manage individual patient needs." Read more