May 29, 2018 — The first placebo-controlled trial that looked at how fractional flow reserve (FFR) and instantaneous ...

Medtronic plc announced the initiation of a U.S. clinical study to assess the safety and efficacy of drug-eluting stents (DES) for the treatment of bifurcation lesions. Bifurcation lesions account for approximately 20 percent of all percutaneous coronary interventions (PCI).[i] The Bifurcation Cohort, part of the RESOLUTE ONYX Post-Approval Study, will include patients with coronary artery disease (CAD) receiving the Resolute Onyx DES in sizes ranging from 2–5 mm in diameter.

Abbott announced favorable outcomes from the first 100 patients treated in a global study of its Tendyne Transcatheter Mitral Valve Replacement (TMVR) system. According to Abbott, Tendyne is the first and only mitral replacement valve that is repositionable and fully retrievable to allow for more precise implantation, helping improve patient outcomes. The trial is the largest study of a transcatheter mitral valve replacement device to date. Results at 30 days demonstrated that Tendyne is associated with a significant reduction of mitral regurgitation symptoms and low mortality rates.

Syncope with bifascicular block may be caused by intermittent complete heart block, but competing diagnoses may coexist. A new study tested whether a strategy of empiric permanent pacing (PM) reduces major adverse events more effectively than acting on the results of an implantable cardiac monitor (ICM). Results of the study were presented at Heart Rhythm 2018, the 39th annual scientific sessions of the Heart Rhythm Society (HRS), May 9-12 in Boston.

Atrial fibrillation patients who are diagnosed with carotid artery disease face higher risks for developing dementia, according to new research from the Intermountain Medical Center Heart Institute in Salt Lake City.

Medtronic announced on May 23, 2018 that it will discontinue marketing for its SEEQ Mobile Cardiac Telemetry (MCT) System to concentrate support on its Reveal LINQ Insertable Cardiac Monitor (ICM) System.

Abbott has initiated a Class I recall of the HeartMate 3 Left Ventricular Assist System due to a malfunction in the device’s outflow graft assembly. The company said the malfunction may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.