Medtronic, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the first U.S. clinical uses of its new Affinity Fusion oxygenation system.

U.S. adolescents’ lack of heart-healthy behaviors may increase their chances of heart disease as adults.

The Society of Thoracic Surgeons (STS) published an executive summary of clinical practice guidelines on aortic valve and ascending aorta procedures in the April issue of The Annals of Thoracic Surgery.

The FDA approved canaglifozin tablets, which with diet and exercise, is used to improve glycemic control in adults with type 2 diabetes.

The TACT trial, and by association its investigators, came under fire with publication of results that found the cardiovascular benefits of chelation therapy to be modest at best. But its sponsor, the National Institutes of Health (NIH), should shoulder a hefty portion of the criticism.

Results of the troubled TACT trial were published March 27 in the Journal of the American Medical Association, a move made even more controversial with the inclusion of two accompanying editorials. But all authors agreed on one point: Routine use of chelation therapy, the focus of the trial, as a treatment for patients who experienced an MI, is not warranted.  

The FDA has proposed that filing a premarket approval application or a notice of completion of a product development protocol be required for automated external defibrillators systems (AEDs) and their accessories.

Abbott Vascular has notified a regulatory agency in the U.K. that it has received four reports of the actuator knob in the MitraClip Clip Delivery System being turned in the wrong direction, which can prevent the successful deployment of the clip and possibly require open surgical repair.