7 Cardiology Headlines You Missed in September 2026

After a packed August, September 2026 was a comparatively quiet month for cardiology. However, despite having less in the way of major conferences and trial readouts, this past month made up for it with several major decisions from the US Food and Drug Administration (FDA) and updates on long-running clinical investigations. From heart failure (HF) and atrial fibrillation to hypertrophic cardiomyopathy (HCM) and hypertension, just about every corner of cardiovascular care saw a significant update over the last 30 days.

As we approach a busy conference season in October, catch up on any major headlines you may have missed from September 2026 with the HCPLive team’s recap below:

FDA News

TactiFlex Duo Ablation Catheter Receives FDA Approval for AFib

On September 8, the FDA approved Abbott’s TactiFlex Duo Ablation Catheter, Sensor Enabled, for patients with atrial fibrillation. The approval was based on 12-month data from the FlexPulse investigational device exemption (IDE) study, which was presented at the European Society of Cardiology and which resulted in a significant proportion of patients free of arrhythmia recurrence, arrhythmic medication changes, or repeat ablation procedures.

FDA Updates Sotatercept Label with HYPERION Data in Early PAH

On September 22, 2026, the FDA officially updated the label of sotatercept-csrk to include efficacy and safety data from the HYPERION trial, which investigated the medication in adults with pulmonary arterial hypertension (PAH). Sotatercept successfully reduced all-cause mortality risk compared to placebo, with no severe reductions in platelet count and consistent safety findings with the previous STELLAR study. However, the updated label does come with additional safety guidance.

FDA Approves Mavacamten for Pediatric Patients With Obstructive HCM

On September 30, the FDA announced their approval of an updated label for mavacamten, allowing its usage in pediatric patients with oHCM. The SCOUT-HCM trial, which enrolled patients between 12 and <18 years, demonstrated substantial reductions in Valsalva LVOT gradient and resting LVOT gradient from baseline. This approval ultimately allows a traditionally undertreated population with substantial unmet need to combat a debilitating disease for the first time.

Trial Results

TRANQUILITY: Pacibekitug Reduces hs-CRP, Inflammatory Biomarkers in CKD

At the European Society of Cardiology 2026, Deepak Bhatt, MD, MPH, MBA, director of Mount Sinai Fuster Heart Hospital, sat down with HCPLive to discuss the results of the TRANQUILITY trial of pacibekitug. The drug efficaciously reduced hs-CRP in patients with chronic kidney disease and elevated hs-CRP compared to placebo. Bhatt and colleagues ultimately concluded that, while these data were conclusive, cardiovascular outcome data are still necessary to determine pacibekitug’s value as an Lp(a) targeting therapy.

H-ISDN Meta-Analysis Lowers Mortality in Heart Failure, With Jawad Butt, MD, PhD

Presented at the European Society of Cardiology 2026 by Jawad Haider Butt, MD, PhD, this meta-analysis demonstrated that hydralazine plus isosorbide dinitrate (H-ISDN) significantly reduces all-cause and cardiovascular death in patients with HF with reduced ejection fraction (HFrEF). Although its effects were less consistent with HF hospitalization, H-ISDN did successfully cut all-cause death risk by 29%.

Conference Insights

ORFAN-MAESTRIA: AI Predicts Cardioembolic Stroke, Atrial Fibrillation from CT Scans

The ORFAN-MAESTRIA trial, presented at the European Society of Cardiology 2026 by Charalambos Antoniades, MD, PhD, of the University of Oxford, highlighted AI’s ability to detect and predict both cardioembolic stroke and atrial fibrillation from routine CT scans. This 10-year trial demonstrated that fully automated phenotyping of the peri-left atrial space enabled for detection of left atrial myopathy and the prediction of cardioembolic stroke from routine CT – however, atrial fibrillation was determined through radiomic phenotyping of the left atrium itself, dissociating the 2 conditions early on.

Don't Miss a Beat: CARDIO-TTRansform and New HF Guidelines at ESC 2026

In this episode of Don’t Miss a Beat, recorded on-site at the European Society of Cardiology 2026, cohosts Stephen Greene, MD, and Muthiah Vaduganathan, MD, MPH, discuss the neutral results of the CARDIO-TTRansform trial and the updated HF guidelines released at the conference. From a new, 2-pillar approach to HF with preserved ejection fraction (HFpEF) to the replacement of guideline-directed medical therapy with more specific terminology, these new guidelines effectively rewrote the implementation of cardiovascular care for the foreseeable future.