Settlement on Defective ICDs; Guidewire Recall; Testicular Pains a Heart Problem?

FDA advisors will be tasked with dissecting the heart safety profile of the anemia drug roxadustat this week. (FiercePharma)

After reviewing more than 300 cases, the European Medicines Agency said that myocarditis and pericarditis should be listed as potential side effects of the Pfizer and Moderna COVID-19 vaccines. Benefits of these vaccines continue to outweigh their risks, however, according to the agency. (Newsweek)

St. Jude Medical agreed to pay $27 million to the U.S. Department of Justice (DOJ) to settle allegations that it knowingly sold defective implantable cardioverter defibrillators — namely the Fortify, Fortify Assura, Quadra and Unify devices prone to premature depletion of the batteries.

Medical device manufacturer Alere, which was accused of knowingly selling defective INRatio blood coagulation monitors since 2008, agreed to pay a more than $38 million to settle the allegations.

People with large losses in cognition and daily functioning appeared to be more prone to a subsequent stroke within a decade. (Journal of Neurology Neurosurgery & Psychiatry)

Cardiology societies stressed the need to reduce administrative complexities and practice inefficiencies in a joint statement on clinician well-being.

Discrimination against transgender adults was linked to heart disease, which prompted the American Heart Association to call for policy changes and special training for clinicians encountering “gender minorities.” (Circulation)

Fast-dissolving ticagrelor (Brilinta) tablets performed similarly to standard pills as loading dose in the setting of acute coronary syndrome patients undergoing immediate percutaneous coronary intervention. (Journal of the American College of Cardiology)

AliveCor’s KardiaMobile 6L personal ECG device was given FDA 510(k) clearance for taking ECGs that can be used to manually calculate the QT interval, the company announced.

Medtronic recalled nearly 55,000 angiographic guidewires because they had been inadequately sterilized before distribution. (FierceBiotech)

Prescription fills for newer heart failure therapies soared during the COVID-19 pandemic, while trends for older generics remained stable, a GoodRx analysis found.

The case of a man with testicular pains who turned out to have cardiac sarcoidosis. (Circulation: Cardiovascular Imaging)

Testosterone-deficient men who chose to undergo long-term testosterone replacement therapy had a lower risk of heart attack and stroke than those who refused therapy, according to a study from the European Association of Urology meeting.

Risk of atrial fibrillation was several-fold higher for athletes such as soccer and rugby players than for non-athletes, a meta-analysis found. (British Journal of Sports Medicine)

Refractory ventricular tachycardia in one Jarvik 2000 left ventricular assist device recipient was successfully treated with open-chest epicardial ablation. (JACC: Case Reports)

After decades of falling admission rates for myocardial infarction, England may be seeing a resurgence of heart attacks. (Journal of Epidemiology & Community Health)

Introducing the PEACH score, a tool for predicting in-hospital mortality after cardiac surgery in adult congenital heart disease. (Journal of the American College of Cardiology)

When one spouse has cardiovascular disease, the other may be at increased risk of suffering cardiovascular events, too. (Circulation: Cardiovascular Quality and Outcomes)

Aspirin users who came down with pneumonia suffered fewer heart attacks and strokes compared with non-users, according to research presented at the European Congress of Clinical Microbiology & Infectious Diseases.

An inflammatory aging “clock,” developed from artificial intelligence, can identify people at risk of cardiovascular disease and immune decline. (Nature Aging)

It is possible to use thin graphene sheets to record electrical activity in living heart cells, scientists found. (WIRED)