St. Jude lands European win for "industry’s smallest high-energy ICD" — St. Jude Medical (NYSE:STJ) landed CE Mark approval in the European Union for its next-generation Ellipse implantable cardioverter defibrillator, a device the St. Paul, Minn.-based device titan bills as the industry’s smallest high-energy ICD.
The Ellipse ICD was designed with feedback from more than 200 physicians from around the world, including concepts from clay models built by physicians during focus groups, according to St. Jude.
"Its thinness, longevity and new discrimination algorithms constitute the answers to the 3 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," Dr. L.R.C. Dekke, the Cardiac Center of the Catharina Hospital in The Netherlands cardiologist who implanted the 1st Ellipse ICD in Europe, said in prepared remarks.
In a separate release, St. Jude also noted the 1st implant in a U.S. Investigational Device Exemption study of its MRI-friendly Accent MRI pacemaker and Tendril MRI leads. The ultimate goal of the study is to determine whether pacemaker patients can safely undergo full-body, high resolution MRI scans. Read more