FDA Approves AcQCross Transseptal Crossing Devices

Patrice Wendling

April 13, 2021

The US Food and Drug Administration has cleared the AcQCross family of universal transseptal crossing devices, Acutus Medical announced today.

"This is the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus' own suite of sheaths and with sheaths sold by other manufacturers," the company says in a news release.

The new and expanded family of AcQCross catheters include versions that are length-, diameter-, and tip-matched and designed to lock into the hub of sheaths now used in the vast majority of left heart procedures, it says.

AcQCross enables mechanical septal crossing with a spring-loaded needle that can also deliver radiofrequency (RF) energy. A retained 0.032 guidewire within the hollow crossing needle further streamlines procedural workflow by eliminating the need for wire and needle exchanges, the company says.

"The optimal septal crossing location and angle differs depending on the procedure — be it cryoablation, RF ablation, noncontact mapping, or left atrial appendage implant — so the unique ability to easily reposition without cumbersome catheter withdrawals and exchanges are benefits that cannot be overstated," Peter Weiss, MD, MSC, Banner University of Arizona Medical Center Phoenix, says in the statement.

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