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Home » FDA clears Acutus’ AcQCross system for use with Boston Scientific’s Watchman

FDA clears Acutus’ AcQCross system for use with Boston Scientific’s Watchman

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Acutus MedicalAcutus Medical (Nasdaq:AFIB) announced today that it launched an expanded suite of left-heart access products.

Following expanded FDA clearance, Acutus launched the suite to now include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Boston Scientific Watchman left atrial appendage closure device.

Carlsbad, California-based Acutus designed the AcQCross system as the first and only transseptal system engineered with an integrated needle and dilator to reduce the exchanges of wires and needles while trying to achieve the proper angle and location on the septum.

The company said in a news release that the latest FDA clearance means it now offers sheath-compatible transseptal access devices that cover 409,000 electrophysiology and structural heart procedures in the U.S.

AcQCross features a range of catheters that are length-, diameter- and tip-matched and designed to lock into the hub of market-leading sheaths used in the majority of left-heart procedures, including the delivery of the Watchman device. Acutus said the expanded offering allows physicians to use AcQCross with their preferred sheaths during virtually any left-heart access procedure.

Dr. Tom Waggoner — director of the structural heart program and cardiovascular research at the Tuscson (Arizona) Medical Center — said in the release that AcQCross gives him the means to reposition easily without withdrawing or exchanging needles or wires, while the new compatibility with Watchman makes procedures “much safer for my patients and far more efficient for me and my team.”

“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,” Acutus interim CEO and CFO David Roman said in the release. “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.”

Acutus’ regulatory win comes on the heels of the sale of its left-heart access portfolio to Medtronic for $50 million in April. The company’s shares, albeit at a low price, are skyrocketing this morning, rising 82% to 98¢ per share.

“AFIB shares are trading significantly higher in pre-market trading; we view this as an incremental, expected win for the company,” BTIG analyst Marie Thibault wrote in a report.

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