Arrhythmia management firm Acutus Medical has received approval from the US Food and Drug Administration (FDA ) and commercially launched an expanded suite of left-heart access products, which now includes the AcQCross Qx system.
This system is designed for use with the TruSeal and FXD delivery system for the Watchman left atrial appendage closure (LAAC) Device.
The AcQCross system is said to be the first and only transseptal access system that includes an integrated dilator and needle to reduce the exchange of wires and needles while achieving the proper angle and location on the septum.
It has a range of length, diameter and tip-matched catheters that are designed to lock into the sheaths’ hub.
These sheaths are used in many left-heart surgeries, including the delivery of the Watchman.
Acutus Medical stated that the expanded product offering will allow physicians to use AcQCross with their preferred sheaths in any left-heart access procedure.
Furthermore, the FDA clearance will allow the company to provide sheath-compatible transseptal access devices for 409,000 electrophysiology and structural heart surgeries in the US.
Acutus Medical interim CEO and chief financial officer David Roman said: “The AcQCross system provides interventional cardiologists and electrophysiologists with unique benefits of broad compatibility with market-leading access sheaths while also enhancing procedure versatility and workflow.
“The expanded AcQCross product line allows us to bring this innovative technology to a wider range of procedure categories that should drive sustained growth in this portfolio.”
In May, the company concluded patient enrolment in its AcQForce Flutter Investigational Device Exemption (IDE) clinical trial.