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.

Medtronic plc announced study results showing its AdaptivCRT algorithm is associated with improved patient survival. The data were presented at Heart Rhythm 2018, the Heart Rhythm Society's 39th Annual Scientific Sessions, May 9-12 in Boston.

LuxCath LLC showcased the next generation of its proprietary OmniView light-guided catheter ablation system at the 2018 Heart Rhythm Society (HRS) conference, May 9-12 in Boston. The OmniView light-guided ablation catheter is the only technology, according to the company, that can see into tissue during cardiac ablation and assess catheter-tissue contact and lesion progression in real time. This offers electrophysiologists a simple and more definitive end point for lesion quality, increasing the potential for complete and more effective cardiac ablation.

Pie Medical Imaging announced that clinical data on its CAAS vFFR (Cardiovascular Angiographic Analysis Systems for vessel Fractional Flow Reserve) software will be presented during EuroPCR 2018, May 22-25 in Paris, France. This software, which has received U.S. Food and Drug Administration (FDA) 510(k) clearance, can calculate the pressure drop and vFFR value in the coronary artery non-invasively, which means there is no need for a pressure wire and hyperemic agent.

May 21, 2018 — Complete pulmonary vein isolation (PVI) was achieved in more than 99 percent of patients in a first-in-man study using the Kardia Globe multi-electrode array catheter ablation system. The late-breaking study was presented at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions.

May 21, 2018 — The available electrophysiology catheter ablation technologies are not designed for use in the ventricular anatomy, so a new needle ablation catheter from Biosense Webster was tested in a study to assessed the safety.[1] The six-month data from the study was presented at Heart Rhythm 2018, the Heart Rhythm Society’s 39th Annual Scientific Sessions.

All of the patients had failed using a standard approach and then using the needle we were able to get rid of their tachycardia

Subscribe Now