Aortic Arch Stent Graft OK’d; AI Cardiac Tool Lawsuit; Mining Head CTs for CVD Risk

The FDA approved Endospan’s Nexus aortic arch stent graft system, a bimodular device designed to mimic the ascending and arch anatomy.

The agency also sent a warning letter to Medline for poor manufacturing practices around its NAMIC angiographic control syringes. Complaints from customers include one case of air embolism and a clinician exposure to a biohazard. (Reuters)

Heartflow sued Cleerly over the misuse of intellectual property related to its artificial intelligence (AI) products for ⁠cardiac imaging. (Reuters)

Anumana said it got FDA clearance for its ECG-AI algorithm for detecting cardiac amyloidosis from a standard 12-lead ECG.

Deep learning models can be applied to perform opportunistic cardiovascular disease (CVD) risk screens from routine head CTs in the emergency department. (Journal of the American College of Cardiology)

With Penumbra’s Lightning Flash computer-assisted vacuum thrombectomy, patients with acute intermediate-high risk pulmonary embolism achieved greater functional improvement over anticoagulation alone, according to the STORM-PE trial.

Do guidelines on passenger fitness to fly for commercial air travel need to be revised to reflect advances in cardiovascular medicine? (Heart)

Real-world results at 12 months support the safety and effectiveness of pulsed field ablation, using the Varipulse platform, for atrial fibrillation (Afib). (EP Europace)

After cardiac surgery, new-onset Afib occurred in one in three patients in a large, international cohort study. (European Heart Journal)

False-positive alerts from implantable cardiac monitors, even AI-equipped ones, remain an issue across manufacturers, Implicity reported.

His bundle pacing and biventricular pacing still came out even for cardiac resynchronization therapy (CRT) in an analysis of long-term data from a small trial. (JACC: Clinical Electrophysiology)

Biotronik announced that people still have better outcomes staying on guideline-directed medical therapy for nonischemic cardiomyopathy even if they got an implantable cardioverter-defibrillator or CRT defibrillator, based on registry data.

It would be cost-effective to rely on apolipoprotein B results to guide primary prevention lipid-lowering therapy, according to an economic modeling study. (JAMA)

Whether outcomes are improved with tenecteplase versus alteplase in patients with large vessel occlusion may hinge on thrombolysis-to-puncture time. (Stroke)

RBM20 truncating variants can be considered low-effect genetic contributors to arrhythmogenic dilated cardiomyopathy. (JAMA Cardiology)