Cardiology. What changed.
New drugs and devices in cardiology, newest first, each with its bottom line.
As of , Clintelo tracks 6 innovations in cardiology: 2 drugs (Lipfendra (enlicitide) and Baxfendy (baxdrostat)) and 4 devices (SELUTION SLR Drug-Eluting Balloon, EchoNext, OmniaSecure defibrillation lead and Trilogy Transcatheter Heart Valve). Each is written from the FDA's announcement or the developer's own release.
Drug IQ in Cardiology
Search 2 in Drug IQ- Drug IQFDA approvalLipfendra (enlicitide)Hypercholesterolemia · MerckAdults who need more LDL-C lowering now have a PCSK9 inhibitor taken as a daily pill. Whether it reduces cardiovascular events has not been shown yet.
- Drug IQFDA approvalBaxfendy (baxdrostat)Hypertension · AstraZenecaAdults whose blood pressure is not adequately controlled on other medicines have an add-on option that works by inhibiting aldosterone production. The pivotal trial enrolled patients already on two or more drugs. Potassium and sodium need to be checked before and during treatment.
Device IQ in Cardiology
Search 4 in Device IQ- Device IQApproved · PMASELUTION SLR Drug-Eluting BalloonCoronary in-stent restenosis · CordisInterventional cardiologists have a sirolimus balloon option for in-stent restenosis that, per the company, helps minimize the need for another stent. The supporting trial showed non-inferiority to standard of care, which was mostly repeat drug-eluting stenting.
- Device IQCleared · 510(k)EchoNextScreening for structural heart disease from an ECG · Pathway LabsA routine ECG can be analyzed to flag patients who should have an echocardiogram for possible structural heart disease. Echocardiography is still required to definitively diagnose these conditions.
- Device IQApproved · PMA supplementOmniaSecure defibrillation leadDefibrillation with conduction system pacing · MedtronicPatients who need both a defibrillator and pacing can now receive conduction system pacing through the defibrillation lead itself, placed in the left bundle branch area.
- Device IQApproved · PMATrilogy Transcatheter Heart ValveSymptomatic, severe aortic regurgitation · JenaValve TechnologyPatients with symptomatic, severe aortic regurgitation who are at high or greater surgical risk now have a transcatheter valve with a dedicated U.S. indication. The company plans to launch first at participating clinical study sites, then at new hospitals.