Acutus Medical is planning to commence the full commercial launch of its AcQCross family of products in the US in the next few weeks
Acutus gets FDA approval for AcQCross devices. (Credit: Ignacio DG from Pixabay.)
Acutus Medical, an arrhythmia management company, has received the US Food and Drug Administration (FDA) approval for its AcQCross family of universal transseptal crossing devices.
The company claimed that its AcQCross is the first and only transseptal puncture system designed to easily pair with the suite of its sheaths, along with other available sheaths.
Acutus is planning to commence the full commercial launch of its AcQCross family of products in the US in the next few weeks.
Acutus Medical president and CEO Vince Burgess said: “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.
“We expect that this product will be quickly and widely adopted by electrophysiologists and interventional cardiologists.”
According to the arrhythmia management company, crossing the septum to access the heart’s left atrium is an important step in atrial fibrillation or left-sided tachycardia ablation and structural heart procedures.
Also, obtaining a proper crossing angle and location of the septal crossing would impact the effectiveness of the entire procedure.
Acutus Medical said that the expanded family of AcQCross catheters comprise versions that are length-, diameter- and tip-matched and compatible with sheaths currently used in most of the left heart procedures.
The unique compatibility would enable physicians to leverage AcQCross with their sheath of choice during any potential left heart procedure.
AcQCross is said to facilitate the mechanical septal crossing with a spring-loaded needle, which can also be enhanced using simultaneous delivery of radiofrequency (RF) energy.
Furthermore, the product incorporates a retained .032 guidewire within the hollow crossing needle, which eliminates the need for wire and needle exchanges and simplifies the procedural workflow.