Acutus Medical announced that it received FDA clearance for its AcQCross family of universal transseptal crossing devices.
Carlsbad, Calif.-based Acutus touts the AcQCross system as the first and only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ suite of sheaths, as well as with sheaths sold by other manufacturers, according to a news release.
The expanded family of AcQCross catheters includes versions that are length-, diameter- and tip-matched and designed to lock into a range of sheaths used in the majority of left heart procedures, including those from both Acutus and other vendors.
AcQCross allows for mechanical septal crossing with a spring-loaded needle that can also concurrently deliver radiofrequency energy while also aiding procedural workflow by eliminating the need for wire and needle exchanges with an incorporated, retained .032 guidewire within the hollow crossing needle.
Acutus said it will begin the full U.S. commercial launch of AcQCross “in the coming weeks.”
“This product is absolutely unique in the industry. We are giving physicians an immensely adaptable and versatile product family developed to provide an enhanced and more precise transseptal approach – and still allow them to continue to use their sheath of choice for the remainder of the procedure,” Acutus president & CEO Vince Burgess said in the release. “We expect that this product will be quickly and widely adopted by electrophysiologists and interventional cardiologists.”
