Cardiology ·
FDA approves first heart valve built to expand as children grow; mavacamten label extends to pediatric patients; ACC issues nutrition statement
THE SHORT READ
The Food and Drug Administration (FDA) approved the Autus Size-Adjustable Valve, the first heart valve designed to be expanded after surgery as a child grows. The agency also extended mavacamten to pediatric patients weighing at least 30 kg with obstructive hypertrophic cardiomyopathy and accepted an application for zalunfiban, an injectable drug for ST-elevation myocardial infarction (STEMI) given at first medical contact. The American College of Cardiology (ACC) published a nutrition statement in JACC.
THE DETAILS
- FDA Oct 1, 2026The Food and Drug Administration approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary valve for children with congenital pulmonary valve disease that can be implanted as small as about 13 millimeters and widened by balloon catheter up to 22 millimeters. Approval rested on a study of 62 pediatric patients at 12 U.S. sites; at six months, the first 60 had acceptable hemodynamic performance. Three patients had valve frame fractures and two had reduced leaflet movement, none with symptoms, and performance declined in two who began to outgrow it. Edwards Lifesciences received the approval; Autus Valve Technologies developed the device.Source: FDA
- FDA Sept 30, 2026The Food and Drug Administration approved an expanded indication for Bristol Myers Squibb's mavacamten (Camzyos) covering adults and pediatric patients weighing 30 kg or more with symptomatic obstructive hypertrophic cardiomyopathy, according to the label. In the SCOUT-HCM trial of 44 patients aged 12 to younger than 18, the Valsalva left ventricular outflow tract gradient fell by a mean of 49.4 mm Hg at week 28 with mavacamten, versus 1.8 mm Hg with placebo. The label keeps the boxed warning for heart failure due to systolic dysfunction, and the drug remains available only through a Risk Evaluation and Mitigation Strategy program.
- Guidelines Sept 30, 2026An American College of Cardiology scientific statement published online in JACC, chaired by Dr. Frank Hu of the Harvard T.H. Chan School of Public Health, calls a healthy dietary pattern a key component of preventing and managing cardiovascular disease, TCTMD reported. It advises limiting ultraprocessed foods, added sugar, excess sodium and saturated fats, and says there is strong evidence for the Mediterranean and Dietary Approaches to Stop Hypertension (DASH) diets. The statement says the overall balance of evidence does not support regular alcohol use for health benefits.
- FDA Sept 30, 2026The Food and Drug Administration accepted CeleCor Therapeutics' new drug application for zalunfiban, an investigational subcutaneously injected inhibitor of the platelet glycoprotein IIb/IIIa receptor for STEMI, and set a target action date of June 18, 2027, the company said. The CeleBrate trial enrolled 2,467 patients with presumed STEMI within four hours of symptom onset; pooled zalunfiban improved the 30-day hierarchical composite primary end point versus placebo (adjusted odds ratio 0.79; 95% CI 0.65 to 0.98), HCPLive reported. Severe or life-threatening bleeding occurred in 1.2% of zalunfiban recipients and 0.8% of placebo recipients (P = .40).Sources: CeleCor Therapeutics, HCPLive
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