Terumo Medical Corp. is recalling the SoloPath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to a potential for the tip to dislodge from the outer rim of the sheath. This may result in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.

Amarin Corp. plc announced that its supplemental new drug application (sNDA) for Vascepa (icosapent ethyl) capsules has been accepted for filing and granted Priority Review designation by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal date assigned by the FDA for this sNDA is Sept. 28, 2019. Because of the Priority Review designation, the timing of this PDUFA date is four months earlier than the anticipated standard ten-month review for applications.

New data demonstrated that use of the investigational HeartFlow Planner, a real-time, non-invasive interactive planning tool, led to a change in treatment strategy in 45 percent of patients with coronary artery disease (CAD) and reduced the need for invasive physiology. The data from the BOWIE (Benefits of Obtaining information for planning With noninvasive FFRCT prior to Invasive Evaluation) study were presented by Eric Van Belle, M.D., Ph.D., professor of cardiology, head of the Lille Heart & Lung Institute, and principal investigator for BOWIE, as a late-breaking trial at the EuroPCR Conference, May 21-24 in Paris, France. The results were also published in the Journal of the American College of Cardiology (JACC).

Researchers have developed the first algorithm that can locate patient-specific ablation targets for atrial fibrillation (AFib) within the atria that does not require specialized catheters or 3-D electro-anatomic maps of the heart. The new algorithm – the iterative catheter navigation (ICAN) – is fundamentally different from existing approaches.