It’s Heart Rhythm Society week and St.Jude is keen to make the world look at the good stuff it’s up to rather than dwell on what must be the taboo subject of “the R word” in its corridors.
To this end it’s issued three announcements in three days, all of which appear to be good news stories for the company.
Firstly it announced on Tuesday that its Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronisation therapy defibrillators (CRT-Ds) had gained FDA clearance. The new implantable defibrillators feature SecureSense™ RV Lead Noise Discrimination, an algorithm that expands the St. Jude Medical ShockGuard® Technology and offers advanced sensing options designed to reduce the incidence of inappropriate shocks for patients with these devices. That announcement can be found here.
Then on Wednesday it trumpeted FDA’s approval of its approval of its Ellipse™ ICD which was itself recently CE marked as we reported here. Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD offers physicians unique design advancements, resulting in the industry’s smallest high-energy ICD. Further information is in the press release, here.
Finally (for now), the company issued a release coinciding with Heart Rhythm 2012 relating to its part in SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial) 10-year follow-up study which has demonstrated ICD therapy to have significantly reduced mortality for at least 11 years in patients with moderate heart failure (HF). The release, which covers many aspects of the study findings can be found here.
“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. These devices directly address this patient concern and provides physicians additional tools to manage individual patient needs,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division.
“We feel collaboration with physicians in regards to the planning and design of our devices is imperative in order to develop truly breakthrough technologies,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “With the launch of the Ellipse ICD and the Assura family of implantable defibrillators, St. Jude Medical is able to provide physicians with a complete portfolio of devices that meet the individualized needs of patients, and our customers’ needs for reliable, efficient technologies.”
About the SCD-HeFT study
“St. Jude Medical is proud to have supported the SCD-HeFT follow-up study, a trial that provides physicians with important information on the long-term efficacy of ICD therapy,” said Dr. Mark Carlson, chief medical officer and senior vice president of research and clinical affairs for the St. Jude Medical Cardiac Rhythm Management Division. “We’ll continue to support trials providing physicians with clinically relevant information that can help them to improve patient outcomes.”
Clinician comments on SCD-HeFT
“While the original findings of the SCD-HeFT trial advanced the standard of care for patients with heart failure, the follow-up data are critical to define long-term ICD mortality benefits,” said Dr. Jeanne Poole, Professor of Medicine at the University of Washington, who presented the data at Heart Rhythm 2012. “The SCD-HeFT findings demonstrate that patients experience the lifesaving benefit of ICD therapy over a decade of clinical heart failure.”
Source: St.Jude Medical Inc., Business Wire