Amid Medtronic sale, Acutus nabs another FDA clearance for left-heart access portfolio

Medtronic’s deal to purchase Acutus Medical’s entire range of left-heart access devices just got a bit sweeter.

Two months after unveiling the agreement—which still has yet to be finalized—Acutus announced Monday that one of the devices set to be sold to Medtronic has received new clearance from the FDA.

The AcQCross Qx system is used in left-atrial appendage closure (LAAC) procedures, in which a small device is implanted within the heart’s left atrium to block blood from entering, with an aim of reducing the risk of stroke in patients with atrial fibrillation.

The Acutus device combines the transseptal needle and vessel dilator needed to puncture a hole through the septum between the left and right atrium, eliminating the need to swap equipment mid-surgery while crossing from one side of the heart into the other.

The new FDA clearance covers an upgraded version of the AcQCross Qx system that’s designed to be used with a broader variety of left-atrial appendage closure devices. Chief among the new additions is the Watchman implant, which maker Boston Scientific has touted as the most widely-used 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,” Tom Waggoner, D.O., an Arizona-based structural interventional cardiologist, said in a statement.

“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,” Waggoner said.

The AcQCross Qx system will be included in Acutus’ upcoming trade-off with Medtronic. Under the terms of their April deal, Medtronic is offering $50 million in an upfront cash payment for Acutus’ entire left-heart access portfolio. The medtech giant will also dole out payments over time as the cardiac devices hit certain sales goals and other milestones—though the companies didn’t disclose any specifics of those additional payouts.

Acutus and Medtronic haven’t indicated when that swap will be finalized. The closing date hinges on another deal Acutus struck earlier this year, this one a $35 million agreement with Deerfield Management Company to refinance Acutus’ existing debt.

Together, those deals will allow the California-based company to “intensify our focus on driving the adoption of our electrophysiology mapping and therapy solutions as well as improving our operational and financial performance,” Vince Burgess, president and CEO, said at the time.