FDAnews
www.fdanews.com/articles/200454-acutus-medical-gets-ce-mark-for-transseptal-system
Acutus Medical Logo

Acutus Medical Gets CE Mark for Transseptal System

December 14, 2020

Acutus Medical’s AcQCross transseptal-access system, a family of products designed to improve safety and efficiency for procedures that require left-heart access, has received the CE mark.

The system includes the company’s AcQCross Qx needle-and-dilator device paired with either the fixed AcQGuide MINI or steerable AcQGuide FLEX introducer sheath.

The products enable physicians to position, reposition and cross the heart’s atrial septum without removing the guidewire, lowering the number of exchanges needed to conduct a variety of heart procedures, including atrial fibrillation ablations, left-atrial appendage closure, and transcatheter mitral-valve repair and replacement.

View today's stories