Abbott is recalling the Ellipse Implantable Cardioverter Defibrillators (ICDs) because electrical failures have been identified and determined to be due to a faulty manufacturing process, causing some aluminum wires to be partially exposed. ICDs which contain aluminum wires that are not fully insulated are prone to electrical shorting of the capacitor. The potential patient impact could be the inability to deliver high voltage therapy. There is currently no available method or procedure to determine which of these devices have this issue prior to failure.

B. Braun Interventional Systems Inc. (BIS) announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR).

Dassault Systèmes announced the five-year extension of its collaboration with the U.S. Food and Drug Administration (FDA). The 3DEXPERIENCE platform will be used to develop a new digital tool to enable more efficient regulatory review of cardiovascular and medical devices. Researchers hope the process will increase industry innovation and pave the way for an efficient path for patients to access safe, effective new treatments for the world’s leading cause of death – heart disease.

Clinical trials are a critical tool for getting new treatments to people who need them, but research shows that difficulty finding the right volunteer subjects can undermine the effectiveness of these studies. Researchers at Cincinnati Children’s Hospital Medical Center designed and tested a new computerized solution that used artificial intelligence (AI) to effectively identify eligible subjects from electronic health records (EHRs), allowing busy clinical staff to focus their limited time on evaluating the highest quality candidates.

The chances of patients experiencing complications after having a cardiac device implanted vary according to where they have the procedure.