Acutus Medical announced the US Food and Drug Administration (FDA) approval and the launch of an expanded suite of left-heart access products to include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Watchman LAAC Device.
Acutus Medical said that the AcQCross Qx system is the first and only transseptal access system with an integrated dilator and needle to reduce exchanges of wires and needles in order to achieve the proper angle and location on the septum.
The FDA clearance will allow the company to offer sheath-compatible transseptal access devices for 409,000 electrophysiology and structural heart procedures in the US.
The system has an array of catheters that are length-, diameter- and tip-matched and designed to lock into the hub of sheaths used in the vast majority of left-heart procedures, including delivery of the Watchman.
The expanded product offering will allow physicians to use AcQCross with their preferred sheaths for almost any left-heart access surgery.
Acutus Medical interim chief executive officer 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.”
Last month, the company completed the patient enrolment in the company’s AcQForce Flutter Investigational Device Exemption (IDE) clinical trial.
