Acutus: FDA Clearance, Commercial Launch of AcQCross™ Line Extension

 Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the commercial launch of an expanded suite of left-heart access products to now include the AcQCross™ Qx system for use with the TruSeal (TM) and FXD(TM) delivery system for the Watchman™ LAAC Device.

Gaining access to the left atrium requires physicians to cross the septum, a multi-step process that often involves the exchange of wires and needles while trying to achieve the proper angle and location on the septum. AcQCross is the first and only transseptal system engineered with an integrated needle and dilator to reduce these exchanges. US Left-atrial appendage closure procedures are expected to total over 50,000 in 2022, according to the Millennium Research Group. With this clearance, Acutus now offers sheath-compatible transseptal access devices that cover 409,000 electrophysiology and structural heart procedures in the US.

https://finance.yahoo.com/news/acutus-medical-announces-fda-clearance-100000088.html