Is Acutus Back on Solid Ground with New FDA Nod?

FDA’s clearance for AcQCross Line Extension could mark a return to the more stable ground Acutus was used to before the pandemic.

Omar Ford

June 27, 2022

2 Min Read
Image courtesy of Iulian Dragomir / Alamy Stock Photo

Acutus Medical is putti 2021 behind with a new nod from FDA.

The Carlsbad, CA-based company has won clearance for the commercial launch of its AcQCross Line Extension, a transseptal access system.

The newly cleared device is for use with the TruSeal and FXD delivery system for Boston Scientific’s Watchman LAAC device.

“Crossing the septum at the proper location is important when doing any left-sided heart procedure, but it can be especially critical to the success of delivering Watchman to the left atrial appendage,” said Tom Waggoner, DO, FACC, FSCAI, FSVM, RPVI, Director, Structural Heart Program and Cardiovascular Research, Tucson Medical Center, Tucson, Arizona. “With AcQCross, I can easily reposition without withdrawing or exchanging needles or wires, so its new compatibility with Watchman has made my procedures much safer for my patients and far more efficient for me and my team.”

AcQCross features an array of catheters that are length-, diameter- and tip-matched and designed to lock into the hub of market-leading sheaths used in most left-heart procedures.

The clearance could be part of a return to stable footing for Acutus. The company saw a bump in shares because of the news. NASDAQ: AFIB crossed the $1 mark Monday but on close Friday had been at 54 cents.

Last year, was shaky for the company as it said macroeconomic headwinds prompted it to develop a restructuring plan that included a workforce reduction.

And in late April, the company sold its left-heart access portfolio to Medtronic for an upfront cash payment of $50 million-plus potential future payments tied to certain milestones and future sales.

In a Monday research note, Marie Thibault commented on Acutus’s recent measures.

“We continue to believe there are advantages to the company’s AcQMap mapping technology, including a rapid and more complete picture of complex arrhythmias, though Acutus is in the early stages of demonstrating commercial traction with the technology,” Thibault said. “With investor focus on Accutus's solvency and financial overhang, shares had been trading below net cash. We think the sale of the left heart access portfolio was the right strategy and we think the company's pulsed-field ablation asset has value, since there are relatively few players in this emerging technology segment.”



About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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